Development and Validation of Stability Indicating Method of Mometasone Furoate by HPTLC

Abstract

Background: There is a need for the simple, fast, reliable, economical, specific and sensitivity stability-indicating high performance thin layer chromatographic (HPTLC) method for the estimation of Mometasone furoate (MF) in semi-solid dosage form.

Results: The chromatographic separation achieved by using ethyl acetate: acetonitrile: toluene: triethylamine (1.5: 1.5: 7: 0.2 v/v/v/v) as the mobile phase and Rf value was found to be 0.63 at 250nm in UV detection. The developed method is validated according to the ICH guidelines for simplicity, accuracy, precision, detection range, range of magnitude and consistency. The method described is linear with a correlation coefficient (R²)> 0.9992 with a concentration range of 200–1000 ng / band. The recovery was found to be 98.08%.The LOD and LOQ were found to be 36.69 ng / band and 111.18 ng / band respectively. Drug is subject to stress conditions of acid hydrolysis, alkaline hydrolysis, oxidative hydrolysis, neutral hydrolysis, photolysis, thermal degradation.

Conclusion: The proposed stability index method can be used to determine the group samples of Mometasone furoate API and pharmaceutical Dosage form.