Abstract

Development and validation of UV spectrophotometric method for simultaneous estimation of metformin hydrochloride and alogliptin benzoate in bulk drugs and combined dosage forms

Author(s): Chirag* and Amrita Parle

Two simple, precise and economical UV spectrophotometric methods have been developed for the simultaneous estimation of Alogliptin benzoate and Metformin hydrochloride in bulk and pharmaceutical dosage forms. Method A is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 277nm and 232nm i.e.λmax of Alogliptin benzoate and Metformin hydrochloride respectively. Method B is Absorbance ratio (Qanalysis method) which is based on measurement of absorption at wavelength of 250nm and 277nm i.e. isoabsorptive point of Alogliptin benzoate and Metformin hydrochloride and λmax of Alogliptin benzoate respectively. Linearity was observed in the concentration range of 5-25μg/ml for Alogliptin benzoate and 1-10μg/ml for Metformin hydrochloride. The accuracy of methods was assessed by recovery studies and was found to be within range of 98-102% for both Alogliptin benzoate and Metformin hydrochloride. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory. Due to non-availability of product the condition of mixture was simulated by using Glucophase® tablets(Metformin hydrochloride 500mg) and API of Alogliptin benzoate was added to it. The proposed methods were successfully applied for the determination of Alogliptin benzoate and Metformin hydrochloride in the mixture.

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