Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Alogliptin and Metformin HCl Drug from Bulk and Pharmaceutical Dosage Form

摘要

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Alogliptin benzoate and Metformin hydrochloride using mobile phase [mixture of Phosphate buffer- pH-3.6 and acetonitrile in the ratio of 65:35] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 235.0 nm was selected as the analytical wavelength. The retention time of ALO and MET was found to be 5.055 and 2.838 respectively. The linearity of the proposed method was investigated in the range of 1-5 μg/ml (r = 0.9998) for ALO and 10-50μg/ml (r = 0.9999) for MET respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.