Abstract
The objective of the current study was to develop simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Alogliptin benzoate and Glibenclamide hydrochloride using mobile phase [mixture of Acetonitrile: Phosphate buffer pH-3.6 and in the ratio of 65:35.The proposed method involves the measurement of Retention time at selected analytical wavelength. 240.0 nm. The retention time of Alogliptin benzoate (ALO) and Glibenclamide 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 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.
Published Version
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