Gohil et al., IJPSR, 2014; Vol. 5(3): 907-912. E-ISSN: 0975-8232; P-ISSN: 2320-5148 International Journal of Pharmaceutical Sciences and Research 907 IJPSR (2014), Vol. 5, Issue 3 (Research Article) Received on 19 October, 2013; received in revised form, 18 November, 2013; accepted, 11 February, 2014; published 01 March, 2014 SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ITOPRIDE HYDROCHLORIDE AND MOSAPRIDE CITRATE BY RP-HPLC METHOD: OPTIMIZATION, DEVELOPMENT, VALIDATION AND APPLICATION TO 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 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 C 18 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 R 2 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. INTRODUCTION: Esomeprazole Magnesium Trihydrate (ESO) is chemically known as bis{6- methoxy-2[(S)-{(4-methoxy-3,5-dimethylpyridine- 2-yl)methane}sulfinyl]-1H-1,3-benzimidiazole, magnesium trihydrate [Figure 1(a)] and used as a proton pump inhibitor for the symptomatic treatment of hyperacidic condition. QUICK RESPONSE CODE DOI: 10.13040/IJPSR.0975-8232.5(3).907-12 Article can be accessed online on: www.ijpsr.com DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.5(3).907-12 Itopride hydrochloride (ITO) is chemically known as N-[[4-(2-dimethyaminoethoxy)phenyl]methyl]- 3,4-dimethoxybenzamide hydrochloride) [Figure 1(b)], it inhibits dopamine and has a gastrokinetic effect. Itopride is indicated for the treatment of functional dyspepsia and other gastrointestinal conditions. Mosapride citrate (MOSA) is chemically known as 4-amino-5chloro-2-ethoxy-N- [[4-[4-flurophenyl)methyl]morpholin-2-yl]methyl] benzamide 2-hydroxypropane [Figure 1(c)]. It is a gastroprokinetic agent that acts as a selective 5HT-4 agonist, which accelerates gastric emptying and is used for the treatment of acid reflux, irritable bowel syndrome and functional dyspepsia. Keywords: Esomeprazole magnesium trihydrate, Itopride hydrochloride, Mosapride citrate, isocratic, RP-HPLC Correspondence to Author: Sadhana Rajput Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Building, Donor’s Plaza, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara – 390 002, Gujarat, India. E-mail id: sjrajput@gmail.com