SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ITOPRIDE HYDROCHLORIDE AND MOSAPRIDE CITRATE BY RP-HPLC METHOD: OPTIMIZATION, DEVELOPMENT, VALIDATION AND APPLICATION TO LABORATORY SAMPLE.Abstract
A simple, rapid, accurate, precise and economical RP- HPLC method with UV detection was optimized, developed and validated as per ICH-Q2 guideline for the simultaneous estimation of Esomeprazole magnesium trihydrate (ESO), Itopride hydrochloride (ITO) and Mosapride citrate (MOSA) in laboratory sample. An optimum condition of separation and detection was developed on a reverse-phase Supelco 516 C18 DB column (250mm×4.6mm i.d., 5µ particle size), using a mobile phase composition of phosphate buffer (20mM, pH-7.4 adjusted with sodium hydroxide):acetonitrile:methanol in the ratio of a 20:20:60 (%v/v) at a flow rate of 1.0 ml/min with UV detection at 275 nm within 6 min with retention time of 3.09, 3.89 and 5.19 for ESO, ITO and MOSA respectively. The standard curves were linear over the concentration range of 2-12 μg/mL, 7.5-45 μg/mL and 1.5-9 μg/mL for ESO, ITO and MOSA respectively with R2 more than 0.999. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification. From the validation results it was concluded that proposed method can be used for the estimation of three drugs in laboratory sample.
Darshan Gohil, Prachi Bhamre, Reshma Jain and Sadhana Rajput*
Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara – 390 002, Gujarat, India
19 October, 2013
18 November, 2013
11 February, 2014