Method Development and Validation for The Simultaneous Estimation of Alogliptin and Metformin Using RP-HPLC Method in Both Bulk and Marketed Pharmaceutical Dosage Form (Research Article)

Author(s): Pratap Kumar Patra* and Adarasupally Deepika

Abstract: Analytical Method Development and Validation for Alogliptin and Metformin in bulk and Combine Dosage Form by RP-HPLC, New method was established for simultaneous estimation of Alogliptin and Metformin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Alogliptin and Metformin by using Symmetry C18 5μm (4.6 x 150mm), flow rate was 1.0 ml/min, mobile phase ratio was Phosphate buffer (0.02M) pH-3.8: Methanol: Acetonitrile (60:20:20%v/v), detection wavelength was 260nm. The retention times of Alogliptin and Metformin were found to be 2.324mins and 4.314mins respectively. The % purity of Alogliptin and Metformin was found to be 99.865% and 99.658% respectively. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Alogliptin and Metformin was found in concentration range of 0μg-36μg and 0μg-39μg and correlation coefficient (r2) was found to be 0.9995 and 0.9998, % recovery was found to be 100.280, %RSD for repeatability was 0.174 and 0.709, % RSD for intermediate precision was 0.093 and 0.937 respectively. The precision study was precise, robust, and repeatable. LOD value was 1.377 and 1.079, and LOQ value was 4.174 and 3.272 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Alogliptin and Metformin in API and Pharmaceutical dosage form.

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