SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ANAGLIPTIN AND METFORMIN HCL BY SECOND DERIVATIVE METHODAbstract
A Simple, accurate, and precise spectrophotometric method (1st order derivative method) was developed and validated for the estimation of Anagliptin and Metformin HCl in synthetic mixture. In this method, Anagliptin was estimated at 244 nm where Metformin HCl showed zero absorbance. Metformin HCl is estimated at 234 nm at which Anagliptin showed zero absorbance. The method was linear over the concentration ranges 2-12 µg/mL for Anagliptin and 5-30 µg/mL for Metformin HCl. The LOD was found to be 0.127 µg/mL for Anagliptin and 0.599 µg/mL for Metformin HCl. The LOQ was found to be 0.387 µg/mL for Anagliptin and 1.817µg/mL for Metformin HCl. In the recovery study, % recovery was 99.55 – 101.65% of Anagliptin and 100.25-100.57% of Metformin HCl. The method was found to be precise as %RSD was less than 2.00 in repeatability, Interday, and intraday precision for Anagliptin and Metformin HCl. The % assay of analyte drugs was found to be 101.42% of Anagliptin and 99.61% of Metformin HCl, which showed good applicability of the developed method.
R. H. Majithia * and A. Khodadiya
SAL Institute of Pharmacy, Opposite Sciences City, Sola Bhadaj Circle, Ahmedabad, Gujarat, India.
31 December 2019
10 April 2020
12 April 2020
01 January 2021