DERIVATIZATION OF NEOMYCIN SULPHATE AND AREA UNDER CURVE METHOD FOR ESTIMATION OF NEOMYCIN SULPHATE AND CLOBETASOL PROPIONATE IN CREAM

Abstract

Neomycin sulphate is official in IP 2018, USP 2004 and BP 2003; which includes Microbial assay (Cylinder Plate assay) for the estimation therefore chemical derivatization of Neomycin Sulphate is done using 1-Fluoro-2, 4-Dinitrobenzene (DNFB); also known as Sanger’s reagent, to make it detectable by UV with good accuracy and precision. A fixed dose combination of Neomycin Sulphate, Clobetasol Propionate and Chlorocresol (preservative) in cream formulation is used to treat different types of Skin infections. The literature review reveals that methods like UV, HPLC, HPTLC, GC-MS etc. have been reported for Neomycin Sulphate and Clobetasol Propionate individually and along with other drugs. But no reported method found in combination for Neomycin sulphate and Clobetasol propionate. A simple, accurate, precise and economical UV spectrophotometric i.e. Area Under Curve Method (AUC) was developed. All the dilutions of drugs were prepared in Methanol: Acetonitrile (50:50). Area under curve was integrated in the wavelength range of 235.0- 245.0 nm, 252.0-262.0 nm and 223.0-233.0 nm for CSP, NMS and CCS respectively. The AUC method for Clobetasol Propionate (CSP), Neomycin Sulphate (NMS) and Chlorocresol (CCS) was found to be linear over the range of 0.8-1.2 μg/ml, 8.0-12.0 μg/ml and 1.6-2.4 μg/ml respectively. The result of analysis was analysed and validated statistically and recovery study was found within range of 98-102%. The % RSD was not more than 2.0 % which indicates good precision. All the validation parameters were carried out according to ICH Q2 (R1) guidelines.