DEVELOPMENT AND VALIDATION OF STABILITY- INDICATING RP-HPLC AND ASSAY METHOD FOR DETERMINATION OF THIOCOLCHICOSIDE IN CAPSULE

摘要

ABSTRACT   In the present work the approach of forced degradation study was successfully applied for the development of stability-indicating assay method for determination of Thiocolchicoside in the presence of its degradation products.  The RP-HPLC separation was carried out on Shimadzu® -HPLC 1100 series using a Phenomenex ODS 5µ C18 column (250×4.6mm) with mobile phase comprising of Acetonitrile: Phosphate Buffer (70:30) pH 3.5 v/v at flow rate of 1.0mL/min and UV detection at 260.0 nm. In stress testing a drug substance or the drug product is exposed to an environment vigorous than the normal i.e. at high temperature, high humidity over the period of time called accelerated stability conditions. The drug was subjected to Solid state analysis which includes Humidity studies (40°C/75% RH), photochemical studies (UV light and sunlight exposure) and Thermal studies to apply stress conditions. The method was validated as per ICH guidelines for accuracy, precision, linearity and range, ruggedness and robustness. The linearity of the proposed method was investigated in the range of 80-120% of label claim; the correlation coefficient for Thiocolchicoside was found to be 0.999. The proposed method was found to be simple, specific, linear and rugged and can be used for routine quality control. Keywords: Thiocholchicoside, HPLC, Stability, dissolution, capsule