{"id":43328,"date":"2022-03-31T11:30:16","date_gmt":"2022-03-31T11:30:16","guid":{"rendered":"https:\/\/biomedpharmajournal.org\/?p=43328"},"modified":"2022-08-29T10:34:36","modified_gmt":"2022-08-29T10:34:36","slug":"development-and-validation-of-a-uv-spectroscopic-method-for-the-analysis-of-black-plum-in-marketed-preparations-using-ethanol-as-a-solvent","status":"publish","type":"post","link":"https:\/\/biomedpharmajournal.org\/staging\/vol15no1\/development-and-validation-of-a-uv-spectroscopic-method-for-the-analysis-of-black-plum-in-marketed-preparations-using-ethanol-as-a-solvent\/","title":{"rendered":"Development and Validation of a UV-spectroscopic Method for the Analysis of Black Plum in Marketed Preparations Using Ethanol as a Solvent"},"content":{"rendered":"

Introduction<\/strong><\/p>\n

Drugs which are made from botanicals, or plants and that are used to cure diseases or to\u00a0maintain health are called herbal drugs. For thousands of years, herbal medicine has been used among the people for the treatment of various diseases.80 percent of the global\u00a0population is estimated to rely on traditional herbal medicine for primary health care1<\/sup>. Many\u00a0consider herbal medicine to offer an alternative treatment for different diseases, especially\u00a0diseases requiring lifelong pharmaceutical medication. It is believed that phytoconstituents\u00a0present in herbal preparations show better compatibility in human system. With the\u00a0increasing usage of herbal drugs, maintaining the safety and efficacy of these drugs have\u00a0become a major concern. Safety and efficacy of drugs must be ensured through\u00a0standardization before the drug entering into the market. It is very difficult to maintain the\u00a0quality of herbal drug formulation due to variation in chemical profile of plant sources and\u00a0these variations is affected by various factors like as growing, harvesting, storage and drying\u00a0processes2-4<\/sup>. This variation can affect chemical constituents as well as pharmacological\u00a0activity of drug. Therefore, it is necessary to develop methods for standardization of\u00a0preparation available in the market5,6<\/sup>.<\/p>\n

Syzygium cumini or black plum is a member of <\/em>Myrtaceae\u00a0family and native to Indian\u00a0subcontinent. It is widely distributed in tropical and subtropical region. It is found in India,\u00a0Pakistan, Bangladesh, Myanmar, China, Indonesia, Ceylon. It is also found in Asia, South\u00a0Africa and Nepal 7-9<\/sup>. It is also cultivated in different parts of the world like as United states\u00a0and Australia due to its great economic importance. It is grown as a fruit producer and as a source of timber.<\/p>\n

S. cumini <\/em>is rich in compounds containing phenolics, flavonoids, glucoside derivative. The leaf extracts contain flavonoids like as quercetin, kaempferol, myricetin, myricitrin and\u00a0gallic acid, ellagic acid, ferulic acid, chlorogenic acid as phenol derivatives 10-12<\/sup>. The stem bark of S. cumini<\/em> contains gallic acid, ellagic acid, \u03b2-sitosterol, betulinic acid, myricetin,\u00a0quercetin, friedelin, epi-friedelanol, eugenin, tyannin and flavonoids13-16<\/sup>. The most widely used parts of S. cumini<\/em> is its seed. The seed contains hydrolysable tannins, phenolic contents,\u00a0eugenol, terpenes. The fruits also contain glucose, gallic acid, citric acid, raffinose, anthocyanins, 7-hydroxycalamenene,oleanolic acid, \u03b2-sitosterol, methyl- \u03b2-orsellinate 17,18<\/sup>.<\/p>\n

S. cumini <\/em>seed is used to treat different types of diseases. It is also reported to have its\u00a0usage in the treatment of diarrhea, stomach-ache, piles, dysentery, digestive\u00a0problems19<\/sup>.Different literature studies prove the usage of its seed has antidiabetic effects.\u00a0Various parts of the Syzygium cumini<\/em> plant act as liver tonic, purifies blood, strengthen teeth\u00a0and gums has a great role in the treatment of ringworm infection of head 20<\/sup>.<\/p>\n

Spectroscopic analysis is a widely used technique in the analysis of herbal drugs.\u00a0Some studies describe the uses of HPLC, HPTLC method in the analysis of different\u00a0polyherbal formulations 21,22<\/sup>. Single or multiple herbs containing preparation like as\u00a0<\/em>Ayurvedic, Unani or polyherbal formulations can be analysed using UV-spectroscopy. In this\u00a0technique, it involves the measurement of ultra violet radiation absorption by the substance in\u00a0solution. Both qualitative and quantitative analysis can be done through this technique. It is a\u00a0simple, accurate, inexpensive technique for the analysis of small amount of sample. This\u00a0technique is based on Beer-Lambert\u2019s law. In the present study, we aimed at development\u00a0and validation of UV-spectroscopic technique according to ICH(Q2) guideline for the\u00a0analysis of S. <\/em>cumini seed in polyherbal formulation23<\/sup>.<\/p>\n

\u00a0Materials and Methods<\/strong><\/p>\n

\u00a0Instruments used<\/strong><\/p>\n

Shimadzu double-beam UV-Vis spectrophotometer (UV-1800 Model) having 1.5 nm\u00a0spectral bandwidth with 10 mm quartz cuvette cell was employed in the assay purpose. UV-probe software version 2.43 was used for data acqui\u00adsition for the studied sample. For\u00a0weighing the standard and sample, analytical balance (Model- Ht224R, Shinkodens-hi Co. Ltd, Japan) was used.<\/p>\n

Materials<\/strong><\/p>\n

S. cumini <\/em>fruits were purchased from local market and seeds were collected from these. Then the seed was identified in the national herbarium of Bangladesh having accession\u00a0no. 50,442. Laboratory grade ethanol was used in analysis and it was bought from Merck Chemicals, India. Three formulations containing S. cumini<\/em> seed were collected available in\u00a0local market. All the other chemicals, kits and reagents employed were of laboratory grade.<\/p>\n

S. cumini<\/em><\/strong> extract preparation<\/strong><\/p>\n

Through proper washing of S. cumini<\/em> seeds, the dust attached to it was eliminated\u00a0properly and was air dried until it is crispy. Then it was ground to powder. About 350 gm of powdered fruit materials were taken in an amber-colored reagent bottle and kept for soaking\u00a0in 1.5 litres of ethanol. The soaked materials-containing container was properly sealed and held for a period of about 14 days with occasional shaking and stirring. The whole mixture\u00a0was filtered using cotton and then Whatman No. 1 filter paper successively to get the clear filtrate. Then concentrated crude seed extract was collected using rotary evaporator through\u00a0evaporation of solvent. Next the concentrated extract was further taken in water bath and air dried for complete drying. The obtained extract was preserved for further analysis.<\/p>\n

Solvent selection<\/strong><\/p>\n

The solubility of S. cumini<\/em> seeds was checked using methanol, ethanol, acetone and ethyl acetate. The extract showed better solubility in ethanol in compare to other solvents.<\/p>\n

Preparation of standard solution<\/strong><\/p>\n

10 mg S. cumini\u00a0<\/em>seeds extract was accurately weighed and taken in a 100 mL volumetric flask, volume was adjusted up to the mark with ethanol. A stock solution having\u00a0concentration of 100 \u03bcg\/mL was found. From the stock solution, standard solution of different concentration (0.1-0.5 \u03bcg\/mL) was prepared by dilution with ethanol.<\/p>\n

Selection of the wavelength<\/strong><\/p>\n

From these prepared solutions, 0.03\u03bcg\/mL solution was scanned in 200-800 nm uv-visible range in 1.0 cm cell using ethanol as blank. The maximum absorbance for this solution was found at 279 nm.<\/p>\n

Standard calibration curve preparation<\/strong><\/p>\n

At 279 nm wavelength, the absorbance of S. cumini\u00a0<\/em>seeds extract was measured at different concentrations (0.1-0.5 \u03bcg\/mL). A calibration curve was plotted between\u00a0concentrations versus absorbance of the extracts and a regression equation was found. From the calibration curve, linearity was observed utilizing a regression equation.<\/p>\n

Validation of method<\/strong><\/p>\n

Validation is an integral part of quality assurance. A good analytical practice cannot be achieved without validation. Method validation is defined as the process that is used to\u00a0ensure that the analytical technique used for a particular test is sufficient for its intended use. Method validation results can be used to assess the efficiency, reliability and accuracy of\u00a0analytical findings. Validation of the developed analytical method was carried out following the guidelines set by International Conference on Harmonization (ICH) which is known as\u00a0ICH Q2 (R1) guidelines 23<\/sup>. The major validation parameters described in the guidelines like as specificity, linearity, range, precision, accuracy and robustness were studied for validation of the method.<\/p>\n

Specificity<\/strong><\/p>\n

Standard solution of S.cumini\u00a0<\/em>seeds extract at the concentration of 0.03 \u03bcg\/mL was analyzed by the proposed method and specificity of the method was studied.<\/p>\n

Linearity\u00a0<\/strong><\/p>\n

Linearity of the method was studied through measuring the absorbance of five standard concentrations of\u00a0S. cumini\u00a0<\/em>seeds extract(0.1-0.5 \u03bcg\/mL) at 279 nm using ethanol as\u00a0blank. A calibration curve was plotted between concentrations versus measured absorbance of the extracts and regression analysis was done from the calibration curve.<\/p>\n

Precision<\/strong><\/p>\n

Precision was established by evaluation of repeatability, intra-day precision and intermediate precision. To evaluate precision, the absorbance of standard which is S. cumini<\/em>\u00a0seeds extract was determined at a concentration of 0.1 \u03bcg\/mL for 6 (six) times in the same day known as repeatability. The absorbance of 3 (three) concentrations of S. cumini<\/em> seeds\u00a0extract standard at a concentration of 0.1 \u03bcg\/mL, 0.3 \u03bcg\/mL and 0.5 \u03bcg\/mL was measured in six let at same day and later on three consecutive days which are known as intra-day precision\u00a0and inter-day precision respectively.<\/p>\n

Accuracy<\/strong><\/p>\n

The accuracy of the proposed method was established by recovery investigation with the addition of known amounts to a pre-analyzed sample solution. For this purpose, known concentrations of S. cumini<\/em> fruits extract standard solution at a concentration of 0.1, 0.2 and\u00a00.3 \u03bcg\/mL were added to three pre-analyzed sample solutions respectively which concentration was 0.2 \u03bcg\/mL. The observed result was used to assess the percentage recovery\u00a0of the standard. Same process is repeated for three times for each concentration24<\/sup>. The percent recovery was calculated using following equation.<\/p>\n

% Recovery = [Ct<\/sub>\/Ca<\/sub>] x100<\/p>\n

Where,<\/p>\n

Ca<\/sub> = Conc. of the S. cumini<\/em> after standard addition;<\/p>\n

Ct <\/sub>= Conc. S. cumini<\/em> in the test sample<\/p>\n

Range<\/strong><\/p>\n

Five different concentration of S. cumini<\/em>seeds (0.1 \u03bcg\/mL,0.2 \u03bcg\/mL,0.3 \u03bcg\/mL,0.4 \u03bcg\/mL and 0.5\u03bcg\/mL) were used for the assessment of the range of the method.<\/p>\n

Robustness<\/strong><\/p>\n

Robustness of the method was studied by analyst to analyst variation and instrument to instrument variation studies. For this purpose, the value of absorbance 0.5 \u03bcg\/mL standard S.\u00a0cumini<\/em> seeds was estimated and % RSD (percentage of relative standard deviation) values were calculated between them (first analyst and second analyst; UV-spectrophotometer of model UV-1800 and UV-1240V).<\/p>\n

Use of proposed method for estimation of S. cumini<\/em> seeds in marketed preparation<\/strong><\/p>\n

0.263 ml S. cumini<\/em> seed containing market preparation, equivalent to 10 mg S. cumini\u00a0<\/em>seed extract was measured and transferred in a separating funnel. 10 ml water was\u00a0added to it and extracted with 15 ml of Chloroform. Then the aliquot was filtered using Whatman No. 1 filter paper and the filtrate was collected. For better extraction, addition of\u00a0ethanol and volume was adjusted up to 100 ml with ethanol. This solution was used as stock for further analysis. A test solution was prepared having concentration of 0.5 \u03bcg\/mL using\u00a0ethanol as diluent. The absorbance of the solution was measured at 279 nm wavelength against ethanol as blank.<\/p>\n

Statistical analysis<\/strong><\/p>\n

All the observed results have been shown as Mean \u00b1 Standard deviation and % RSD.<\/p>\n

Results and Discussion<\/strong><\/p>\n

Method development<\/strong><\/p>\n

Different solvents like methanol, ethanol and ethyl acetate were used to determine the solubility, peak quality and peak shape of the studied drug. Among these, ethanol fulfilled all\u00a0criteria in showing better solubility and giving better peak quality. The sample showed maximum absorbance at 279 nm which is shown in Figure 1.<\/p>\n

Method validation<\/strong><\/p>\n

The developed method was validated according to the rules of ICH Q2 (R1) guidelines and the found results were summarized in Table 1.<\/p>\n

Table 1:\u00a0Obtained results of validation parameters by developed UV method.<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Validation parameters<\/strong><\/td>\nObtained results<\/strong><\/td>\n<\/tr>\n
Absorption maxima (\u03bbmax<\/sub>)<\/td>\n279 nm<\/td>\n<\/tr>\n
Limit of Beer\u2019s Law (\u03bcg\/mL)<\/td>\n0.1-0.5<\/td>\n<\/tr>\n
Equation for Regression (y=mx +c)<\/td>\ny = 1.3273x + 0.0441
\nR\u00b2 = 0.9914<\/td>\n<\/tr>\n
Slope<\/td>\n1.3273<\/td>\n<\/tr>\n
Intercept<\/td>\n0.0441<\/td>\n<\/tr>\n
Correlation coefficient<\/td>\n0.9914<\/td>\n<\/tr>\n
\u00a0 % RSD of Repeatability, (n=6)<\/td>\n0.7950<\/td>\n<\/tr>\n
Accuracy<\/td>\n99.647-101.767%<\/td>\n<\/tr>\n
Precision (% RSD)<\/td>\nIntra-day = 0.924; 0.571; 0.467<\/p>\n

Inter-day= 0.892; 0.835;0.342<\/td>\n<\/tr>\n

\n

Robustness (% RSD)<\/p>\n<\/td>\n

\n

0.825; 0.361<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Specificity<\/strong><\/p>\n

The ability of an analytical method to reliably measure an analyte in the presence of interferences that may be present in the sample matrix is referred to as specificity. It signifies\u00a0that the presence of excipients in formulation does not interfere with the drug peak. The result\u00a0of specificity is represented at figure 1 and the result indicates the proposed method was\u00a0found specific and selective for the drug.<\/p>\n\n\n\n
\"Vol15No1_Dev_Sab_fig1\"<\/a><\/td>\nFigure 1: UV spectrum of S. cumini<\/em> seed in ethanol (a). Whole spectrum of S. cumini<\/em> seed and (b) Zoomed spectrum of S. cumini<\/em> seed.<\/strong><\/p>\n

Click here to view figure<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Linearity and range<\/strong><\/p>\n

Linearity refers to a method’s ability to achieve test results that are proportional to the analyte concentration in the sample. The range of an analytical method is the distance\u00a0between the upper and lower levels that have been demonstrated to be calculated with precision, accuracy, and linearity using the set method.<\/p>\n\n\n\n
\"Vol15No1_Dev_Sab_fig2\"<\/a><\/td>\nFigure 2:<\/strong> Linearity and range study of the developed UV method.<\/strong><\/p>\n

Click here to view figure<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

A good linear correlation was achieved between absorbance and concentration in the range of 0.1 \u2013 0.5 \u00b5g\/ml. A linear regression equation was found to having a slope of 1.327, intercept of 0.0441 and the coefficient of correlation value is 0.9914 (Figure 2). The result of linearity is represented in Table 2<\/p>\n

Table 2:\u00a0Linearity and range study of the developed UV method.<\/strong><\/p>\n\n\n\n\n\n\n\n\n
S. cumini<\/em><\/strong> seed standard conc. (\u03bcg\/mL)<\/strong><\/td>\nAbsorbance (279 nm) (Mean\u00b1SD)<\/strong><\/td>\n% RSD<\/strong><\/td>\n<\/tr>\n
0.1<\/td>\n0.201\u00b10.002<\/td>\n1.034<\/td>\n<\/tr>\n
0.2<\/td>\n0.283\u00b10.003<\/td>\n0.935<\/td>\n<\/tr>\n
0.3<\/td>\n0.432\u00b10.003<\/td>\n0.694<\/td>\n<\/tr>\n
0.4<\/td>\n0.577\u00b10.005<\/td>\n0.794<\/td>\n<\/tr>\n
0.5<\/td>\n0.718\u00b10.003<\/td>\n0.418<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Precision<\/strong><\/p>\n

The degree of agreement among individual test results, when a procedure is replicated on multiple samples of the same homogeneous sample is called precision. Precision is\u00a0calculated by injecting a set of standards or examining several samples from a homogeneous lot. Precision as relative standard deviation (percent RSD) is determined using the observed\u00a0standard deviation (SD) and Mean values. Precision can be established through determination of intraday precision, inter-day precision and repeatability. Intraday precision refers to the use of an analytical technique in a laboratory over a short period of time by the same operator with the same equipment, while inter-day precision refers to the calculation of differences in analysis when a process is used in a laboratory on various days by different analysts. A selected concentration 0.1 \u00b5g\/ml, 0.3 \u00b5g\/ml and 0.5 \u00b5g\/ml were analysed in six-let for intra-day and inter-day precision and 0.1 \u00b5g\/ml was analysed for repeatability. The obtained results of precision (intraday precision, inter-day precision and repeatability are represented in Tables 3 The value of Standard Deviation, % RSD for the intra-assay precision, intermediate precision and reproducibility for all the three concentration showed an excellent intraday precision, intermediate precision and reproducibility of the proposed method.<\/p>\n

Table 3:\u00a0Results of precision (intermediate precision, intra-day precision and repeatability) of the developed method.<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Intra-day precision of S. cumini<\/em> seed standard (n=6)<\/strong><\/td>\n<\/tr>\n
S. cumini seed standard conc. (\u00b5g\/ml)<\/strong><\/td>\nAbsorbance (279 nm)<\/strong><\/td>\n% RSD<\/strong><\/td>\n<\/tr>\n
0.1<\/td>\n0.234\u00b10.002<\/td>\n0.924<\/td>\n<\/tr>\n
0.3<\/td>\n0.432\u00b10.002<\/td>\n0.575<\/td>\n<\/tr>\n
0.5<\/td>\n0.735\u00b10.003<\/td>\n0.467<\/td>\n<\/tr>\n
Inter-day precision of S. cumini seed standard (n=3)<\/strong><\/td>\n<\/tr>\n
0.1<\/td>\n0.233\u00b10.002<\/td>\n0.892<\/td>\n<\/tr>\n
0.3<\/td>\n0.432\u00b10.004<\/td>\n0.835<\/td>\n<\/tr>\n
0.5<\/td>\n0.736\u00b10.002<\/td>\n0.004<\/td>\n<\/tr>\n
Repeatability (n=3)<\/strong><\/td>\n<\/tr>\n
0.1<\/td>\n0.2250\u00b10.002<\/td>\n0.342<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Accuracy<\/strong><\/p>\n

The accuracy of an analytical method is defined as the degree of closeness of the test results obtained by that method to the true value. It is also known as trueness. Accuracy was determined by injecting a known concentration of standard to a pre-analysed sample using the “method being validated.” The % recovery for the standard addition and reference analysis method for all the three concentration levels found are 101.767% with % RSD 0.644, 101.943% with % RSD 0.7942 and 99.647% with % RSD 0.426. From the obtained result, this high degree of confidence interval signifies that any small change in the sample concentration can be accurately determined with high level of accuracy. The results found from the standard addition and reference analysis method were also found signifies the accuracy of the proposed method.<\/p>\n

Table 4: Accuracy study data of the developed UV method.<\/strong><\/p>\n\n\n\n\n\n\n
Starting amount<\/strong><\/p>\n

of <\/strong>S. cumini<\/em><\/strong> seed<\/strong><\/p>\n

(\u03bcg\/mL)<\/strong><\/td>\n

Added amount of <\/strong>S. cumin<\/em><\/strong>i<\/em>seed (\u03bcg\/mL)<\/strong><\/td>\nExpected conc. (\u03bcg\/mL)<\/strong><\/td>\nObtained conc.\u00a0\u00a0 (\u03bcg\/mL)<\/strong><\/td>\nResidual conc. (\u03bcg\/mL)<\/strong><\/td>\n\u00a0mean recovery percentage<\/strong><\/td>\n% RSD<\/strong><\/td>\n<\/tr>\n
0.2<\/td>\n0.1<\/td>\n0.3<\/td>\n0.305<\/td>\n0.005<\/td>\n101.767<\/td>\n0.694<\/td>\n<\/tr>\n
0.2<\/td>\n0.2<\/td>\n0.4<\/td>\n0.408<\/td>\n0.008<\/td>\n101.943<\/td>\n0.794<\/td>\n<\/tr>\n
0.2<\/td>\n0.3<\/td>\n0.5<\/td>\n0.498<\/td>\n0.002<\/td>\n99.647<\/td>\n0.425<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Robustness <\/strong><\/p>\n

The terms robustness is an analytical method’s ability to remain unaffected by minor changes in its parameters. The results of robustness are shown in Tables 5.<\/span><\/p>\n

Table 5:\u00a0Robustness study of the developed UV method by analyst and instrument.<\/strong><\/p>\n\n\n\n\n\n\n\n
Studied parameters<\/strong><\/td>\nAbsorbance at 279nm<\/strong><\/p>\n

(Mean\u00b1SD)<\/strong><\/td>\n

% RSD between sample<\/strong><\/td>\n\u00a0Mean Recovery percentage<\/strong><\/td>\n% RSD between two analysts<\/strong><\/td>\n<\/tr>\n
Analyst 1<\/td>\n0.718\u00b10.003<\/td>\n0.425<\/td>\n101.531<\/td>\n0.825<\/td>\n<\/tr>\n
Analyst 2<\/td>\n0.710\u00b10.002<\/td>\n0.282<\/td>\n100.353<\/td>\n<\/tr>\n
Instrument 1<\/td>\n0.717\u00b10.005<\/td>\n0.688<\/td>\n101.296<\/td>\n0.361<\/td>\n<\/tr>\n
Instrument 2<\/td>\n0.720\u00b10.002<\/td>\n0.289<\/td>\n101.814<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

To study robustness, the same sample of same at a same concentration (0.5 \u03bcg\/mL) was analyzed in triplicate by two different analysts (first and second analysts) and in two different instruments (UV-Jasco V-630 and UV-Secom am XTD6). The values of % RSD in both the parameters appeared to be <2 %. This result confirms robustness of the method.<\/p>\n

Estimation of S. cumini<\/em> seed in market preparation<\/strong><\/p>\n

The result of the assay of S. cumini<\/em> seed in market preparation is shown in Table 6.<\/p>\n

Table 6:\u00a0Assay results for S. cumini<\/em> seed estimation in S. cumini<\/em> seed market preparation.<\/strong><\/p>\n\n\n\n\n\n\n
Formulation<\/strong><\/td>\nTested conc. of <\/strong>S. cumin<\/em><\/strong>i<\/em> seed in market preparation <\/strong><\/td>\nAbsorbance at 279 nm<\/strong><\/p>\n

(Mean \u00b1 SD)<\/strong><\/td>\n

% RSD<\/strong><\/td>\nObserved conc. of <\/strong>S. cumin<\/em><\/strong>i<\/em> seed in market preparation<\/strong><\/td>\nMean recovery<\/strong><\/p>\n

percentage<\/strong><\/td>\n<\/tr>\n

A<\/td>\n0.5 \u03bcg\/mL<\/td>\n0.614\u00b10.0035<\/td>\n0.574<\/td>\n0.416\u03bcg\/mL<\/td>\n83.152<\/td>\n<\/tr>\n
B<\/td>\n0.5 \u03bcg\/mL<\/td>\n\u00a0 0.634\u00b10.0050<\/td>\n0.973<\/td>\n0.434\u03bcg\/mL<\/td>\n86.821<\/td>\n<\/tr>\n
C<\/td>\n0.5 \u03bcg\/mL<\/td>\n0.659\u00b10.0040<\/td>\n0.607<\/td>\n0.045\u03bcg\/mL<\/td>\n90.082<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

The developed method has been successfully used to estimate S. cumini<\/em> seed in market preparations. A, B, C three market preparations were collected from the market and the percentage of S. cumini seed was determined. It was found to be 83.152 %, 86.821 % and 90.082 % with % RSD value 0.574, 0.973 and 0.607 respectively as shown in Table 6.<\/p>\n

Conclusions<\/strong><\/p>\n

In conclusion, a simple, reliable, accurate and reproducible method has been developed and validated for analysis of S. cumini<\/em> seed containing formulation. The developed method needs low cost, have faster speed with satisfactory precision. The method also has good specificity. The developed method was successfully validated following the guidelines of ICH and it could be employed for quality control analysis of S. cumini<\/em> seed in market preparation.<\/p>\n

Acknowledgment<\/strong><\/p>\n

The authors would like to thank the Department of Pharmacy, Southeast University, Banani, Dhaka, Bangladesh for providing all the facilities to perform the research work.<\/p>\n

Conflict of Interest<\/strong><\/p>\n

The authors declare that there are no conflicts of interest.<\/p>\n

Funding Sources<\/strong><\/p>\n

This research is conducted through self funding.<\/p>\n

Reference<\/strong><\/p>\n

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