Simultaneous Estimation of Montelukast and Bambuterol in Tablet Dosage forms by RP-HPLC

Appala Raju¹ J.  Venkateswara Rao², K. Vanitha Prakash¹ and K.  Mukkanti^¹

²Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant, Road No# 3, Banjara Hills, Hyderabad.

^¹Centre For Environment IST Building, JNTU, Kukatpally, Hyderabad.

Abstract: A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Montelukast & Bambuterol in tablet dosage forms. An Inertsil ODS-3CV C18, 250x4.6 mm, coloumn with 5 µm particle size and the mobile phase consisting of 0.1% Trifluoro Acetic acid: Methanol in the ratio of 10:90 v/v was used. The flow rate was 0.8 ml/min and the effluents were monitored at 220 nm. The retention times were 2.373min for bambuterol and 6.899 min for Montelukast. The detector response was linear in the concentration of 17.5-420 mcg/ml. The respective linear regression equation being Y= 26705.167x+67644.9694 for Bambueterol and Y=75702.306x+114141.09 for Montelukast. The limit of detection (LOD) is 0.175mcg and 0.35 mcg for Bambuterol and Montelukast respectively. The limit of quantification (LOQ) is 0.525mcg for Bambuterol and 1.05mcg for Montelukast. The percentage assay of Montelukast & Bambuterol was 99.48 % and 99.78% respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Montelukast & Bambuterol in bulk drug and in its pharmaceutical dosage forms.

Keywords: Montelukast and Bambuterol; RP-HPLC; estimation; tablets

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