DEVELOPMENT AND VALIDATIONRP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINETION OF LOPERAMIDE HYDROCHLORIDE AND NORFLOXACIN IN PHARMACEUTICAL FORMULATIONAbstract
A reverse-phase liquid chromatographic (RP-HPLC) method was developed for the determinations of loperamide hydrochloride and norfloxacin in their marketed formulation and bulk. The separation was carried out using mobile phase of triethylamine and acetonitrile (50:50%) with pH 4.The pH adjusted with orthophosphoric acid. The column used was Capcell pack C18 Column (250mn x 4.6mm, 5mm) and flow rate of 1 ml/min. Detection carried out at 213 nm. The retention time loperamide hydrochloride 5.6 and norfloxacin were found to be 2.1 min respectively. Developed method was validated according to ICH guideline. Linearity was observed at concentration rang of 2-6 mg/ml for loperamide hydrochloride and 200-600 mg/ml for norfloxacin. The regression equation were found to be Y=48615x-435565 and Y=72087x-14016 the correlation coefficient (r2) 0.9996 and 0.9988 norfloxacin and loperamide hydrochloride respectively. The percentage RSD for the method precision was found to be less than 2%. The accuracy is found in 98-101 %. The proposed method is precise, accurate, selective and rapid for simultaneous determination of loperamide hydrochloride and norfloxacin
A. M. Sonawane *, P. B. Dudhe, N. H. Chalke and K. B. Bhagat
Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune- 411041, Maharashtra, India.
04 March, 2016
08 April, 2016
31 May, 2016
01 August 2016