AUC, 2nd order Derivative UV Spectrophotometry and RP-HPLC Assay of Vildagliptin

Abstract

There are three simple, new, accurate and precise methods developed and validated on the basis of ICH guidelines for estimation of Vildagliptin in pure and its tablet. Method 1: In UV–Spectrophotometric method two wavelengths 200nm to 210nm were selected for determination of Area Under Curve using scaling factor 1. Area was calculated between 200nm and 210nm by using LAB Solution UV-Vis software having version1.11. Method 2: 2nd Order derivative utilizing 215nm for estimation purposes. The linearity and range were found to be 5 to 40µg/ml for method 1 & 2. The sample and standard solutions were prepared in the double distilled water. Method 3 comprises RP-HPLC method using Enable column C18 and mobile phase (Methanol & water in the ratio of 70 and 30). The flow rate of 1 ml/min, with detection at 198 nm and temperature 22⁰ C were used for analysis purposes. The retention time was found to be 3.228 min. The linearity range was found to be 5-100µg/ml. % RSD is less than 1.5 in the precision, recovery, and robustness studies of the proposed method. So, the method was precise, accurate, sensitive, repeatability, reproducibility and robust in nature. The observed students ‘t’ test values for all the three methods are within the acceptable range for tablet and recovery studies at 95 percent confidence level.