A VALIDATED RP- HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND DICYCLOMINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATIONSAbstract
A reversed-phase-liquid chromatographic (RP-HPLC) method was developed for the determination of Paracetamol (PCM) and Dicyclomine Hydrochloride (DICY) in their bulk drug and marketed formulations. A reversed-phase C-18 Phenomenex C18 column (250 mm × 4.6 mm i.d., 5μm) with mobile phase consisting of Acetonitrile: Phosphate Buffer pH (5.5): triethylamine (75:25:0.02 v/v/v) was used with 1.0 ml/ min flow rate and detected at 218 nm. The retention times of Paracetamol and Dicyclomine Hydrochloride were found to be 2.65±0.3 min and 11.32±0.3 min, respectively. Developed methods were validated according to ICH guidelines. Linearity was observed at concentration range of 100-500 µg/ml for Dicyclomine Hydrochloride and 10-50 µg/ml for Paracetamol followed by Beer’s law. The % recoveries of Paracetamol and Dicyclomine Hydrochloride were found to be between 101.05-101.20% and 100.55-100.95%. The percentage RSD for the method precision was found to be less than 2%. The proposed method is precise, accurate, selective and rapid for simultaneous determination of Dicyclomine Hydrochloride and Paracetamol.
Roshni J. Hedpara*, Vibhuti Chhatarala and Ashwin Agola
Department of Quality Assurance, N. R. Vekaria Institute of Pharmacy, C. L. College Campus, Bilkha Road, Junagadh-362001, Gujarat, India
24 January, 2013
14 April, 2013
12 May, 2013
01 June, 2013