Optimization of RP-HPLC Method for Determination of Alogliptin Benzoate in Bulk and Dosage Form

Author(s): Shubhangi C. Daswadkar, Madhumita A. Roy, Sanjay G. Walode and C. B. Mahendra Kumar

A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for estimation of Alogliptin benzoate in bulk drug and tablet dosage form. The drug was separated using a mobile phase acetonitrile: water, (40:60 v/v) on an Agilent, TC C18 (250 × 4.6 mm) 5 μm column at flow rate of 1.0 mL min-1 at ambient temperature and detection was performed at 277 nm. The detector linearity was established in concentrations ranging from 5-50 μg mL−1, the regression coefficient was 0.9997. For stability study, the drug was exposed to the stress conditions such as acid, base, oxidation, neutral and sunlight as per the recommendations of ICH guidelines. The results of the analysis were validated in terms of specificity, limit of detection, limit of quantification, linearity, precision and accuracy. As per ICH guidelines results were found to be satisfactory. The method was proved to be robust with respect to changes in flow rate and temperature. The high recovery and low relative standard deviation confirm the suitability of these methods can be employed for the routine analysis of tablet containing Alogliptin.

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