Abstract

RP-HPLC METHOD FOR ASSAY AND RELATED SUBSTANCES OF SALBUTAMOL AND CIPROFLOXACIN IN A NOVEL DRY POWDER FORMULATION

Sunita Ameet Sule* and Sushama Raju Ambadekar

Abstract

A stability-indicative reverse phase high-performance liquid chromatography method has been developed and validated to simultaneously estimate Salbutamol and Ciprofloxacin and their related substances in a novel dry powder formulation for inhalation. Chromatographic separation was achieved using a 25 cm C18 column with uv detection at 225 nm. The mobile phase consisted of buffer - Potassium dihydrogen phosphate, Hexanesulphonic acid sodium salt: Acetonitrile, 80:20. The method was validated in line with ICH guidelines and was found to be specific, linear, precise, accurate and robust. In the recovery studies, the % RSD ranged between 90-110% for the Assay and 90-120% for the Related Substances. The co-eff of linearity was greater than 0.999 for Salbutamol, Salbutamol Imp D, Ciprofloxacin and its impurity C. The RSD for Inter-day and Intra-day Precision was less than 2% for the test of Assay and less than 10 % for the test of Related Substances. The degradation studies were carried out in acidic, basic, oxidative, thermal and photolytic conditions. Salbutamol exhibited higher degradation in acidic and basic conditions, while Ciprofloxacin was susceptible to oxidative degradation. There was no interference from the formulation components or related substances.

Keywords: Salbutamol, Ciprofloxacin, Validation, Forced degradation, ICH guidelines.