Estimation of Vildagliptin and Metformin HCl in Bulk and Pharmaceutical Dosage Form (Research Article)

Author(s): N. Karnakar, M. Nagaraju, R. Narsimha Rao and P. Amani

Abstract: A new method was established for simultaneous estimation of Metformin and Vildagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Metformin and Vildagliptin by using Zodiac sil RPC18 4.5x100mm column 3.0μ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol:phosphate buffer(KH2PO4and K2HPO4)-pH 3 ( pH was adjusted with orthophosphoric acid),detection wave length was 271 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 1.694mins and 3.334 mins. The % purity of Metformin and Vildagliptin was found to be 100.27% and 99.87% respectively. The system suitability parameters for Metformin-and Vildagliptin such as theoretical plates and tailing factor were found to be 2993, 1.23 and 5735, 1.12, the resolution was found to be 10.69. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Metformin and Vildagliptin was found in concentration range of 50μg-250μg and 5μg-50μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.18% and 99.38%, %RSD for repeatability was 0.1 and 3.1, % RSD for intermediate precision 1 was 0.7 and 0.8, % RSD for intermediate precision 2 was 0.5 and 0.5 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.17 and 6.60, and LOQ value was 0.032 and 0.1125 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Metformin and Vildagliptin in API and Pharmaceutical dosage form.

PAGES: 148-153  |  172 VIEWS  262 DOWNLOADS