Development and validation of Stability Indication RP-HPLC Assay Method for Estimation of Resveratrol and Orlistat in Capsule Dosage form

Abstract

A stability indicating RP-HPLC method was developed and validated for the quantitative determination of resveratrol and orlistat in capsule dosage form, using Kromasil C18 column 150 mm x 4.6 mm, 5 μm particle size in gradient mode, with mobile phase A consisted of Perchloric acid and mobile phase B consisted of ACN:MeOH (50:50). The detection wavelength was carried out by PDA detector at 215 nm. The retention time for RES was 5.45 min and ORL was 14.15 min. The ORL and RES over linearity in the range of 50% to 150% and recovery were found to be 99.2 – 101.8% and 100.0 – 101.7 % respectively. The % RSD of precision was 0.4% for both drug. The capsule was subjected to stress condition of acid hydrolysis, alkali hydrolysis, peroxide oxidation, thermal degradation and humidity degradation. Percentages of degraded products were 10.26, 9.90 and 19.45 for acid, alkali and peroxide respectively. It is stable in thermal and humidity degradation. No interference of degradation product was found at the retention time of principal peak. The assay can be recommended for analysis of the API and capsule degradation products in stability sample. It may be applied to a routine analysis in industries.