DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING METHOD FOR ESTIMATION OF CETILISTAT IN BULK AND TABLET MARKETED FORMULATION BY USING RP-HPLC AND SPECTROSCOPY METHOD IN FORCED DEGRADATION EXPERIMENTS

Abstract

In the current study, estimation of cetilistat by Uv spectroscopy, reverse -phase Chromotography method in pharmaceutical dosage form and bulk form was developed, In the Uv-Visible Spectroscopy method cetilistat was quantified at 306 nm absorption maxima using 6.5 ph Phosphate Buffer as the solvent. In the RP-HPLC method, the chromatogram was run through a SunFire C18 Column (100Å, 5.0 μm, 4.5 mm X 150 mm) with a mobile phase of 0.01N potassium dihydrogen phosphate: methanol in a 70:30 ratio. The temperature was kept at 30°C and the optimized wavelength was 306.0nm. The flow rate was 0.6ml/min, Analytical calibration curves by Uv were linear within a concentration range from 7.5 to 22.5 μg/ml and coefficient of correlation 0.999, Retention time of Cetilistat was found to be 2.483 min. %RSD of the Cetilistat were and found to be 0.5%. %RSD of Method precision of Cetilistat was found to be 0.9%. %Recovery was obtained as 100.26% for Cetilistat. LOD, LOQ values obtained from regression equation of Cetilistat were 0.22, 0.68, Regression equation of Cetilistat is y = 39410x + 46549, The procedures were validated using the International Conference on Harmonization's (ICH) standard Q2 (R1). The degradation conditions were used in accordance with ICH recommendations Q1A(R2) and Q1B, which include acid, alkaline, neutral, thermal, and photostability, to test the drug's intensity of stability, Based on analytical results, the HPLC method is best for cetilistat quantification tablet formulation due to its high reproducibility, good retention time and sensitivity; it has a higher percent recovery and has less analysis time, i.e., 5 min. The degradation peaks were well separated from the cetilistat peak indicating stability of the HPLC method.