STABILITY-INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION OF FLURANDRENOLIDE IN API AND IT’S LOTION

Abstract

HPTLC stability indicating method has been developed for determination of anti-psoriasis drug, flurandrenolide in API and its formulation. The method was constructed on high performance thin layer chromatography separation of the drug followed by densitometric measurements of their spots at 238 nm. The separation was carried out on Merck TLC aluminium sheets of silica gel 60F254 using toluene: acetone in the ratio of 6: 4 v/v as a mobile phase. The method was validated in accordance with the requirements of ICH guidelines. Calibration curves were linear in range of 200-1200 ng/µl for flurandrenolide and correlation coefficient of calibration curve was found to be 0.9997 respectively. Limit of detection and limit of quantification were found to be 29.7ng/µl and 90.0ng/µl. Method had an accuracy of 100.09% for flurandrenolide in lotion. The developed simple, accurate, precise, specific and reproducible HPTLC method is successively applied to determine flurandrenolide in its lotion formulation.