Validated Area Under Curve and Zero Order Spectroscopic Methods for Estimation of Agomelatine in Bulk and Pharmaceutical Tablet Dosage Form

Abhijit S. Salokhe^1,2, Shubham Malkar¹, Shubham Mangule¹, M. S. Palled¹, Shailendra S. Suryawanshi^1*and Panchaxari M. Dandagi²

¹Department of Pharmaceutical Chemistry, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Belagavi- 590010, Karnataka, India.

²Department of Pharmaceutics, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Belagavi- 590010, Karnataka, India.

Corresponding Author E-mail: shailendrasuryawanshi@klepharm.edu

Abstract: The objectives of present research work was to develop simple, precise, accurate, specific, cost effective, validated UV-spectrophotometric method for quantification of Agomelatin (AGM) in bulk and pharmaceutical tablets dosage form by Area Under Curve (AUC) and Zero Order Spectroscopic (ZOS) methods. Both methods involve the use methanol: millipore water (50:50 %v/v) as solvent for estimation. The area between 212-237 nm was used to measure the AUC for first method and 229 nm was used to measure the absorbance for second method.  The developed technique was optimized and standardized as per ICH guidelines in terms of specificity, selectivity, linearity, ruggedness, solution stability, quantification and detection limits, precision, robustness, and accuracy. Both methods showed linearity between the amount ranges from 0.5 – 2.5μg/mL. The % RSD for all the validation parameters was found to be less than 2%. Both methods were found to accurate with recovery values. The results obtained by proposed method showed that method is linear, specific, selective, rugged, precise, stable, robust, and accurate and can be employed for the quality control of AGM in bulk and tablet formulation.

Keywords: Agomelatine; Area under curve; ICH guidelines; Validation; Zero Order Spectroscopy

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