Development of Liquid Chromatographic Method for Estimation of Ondansetron and Ranitidine in Combined Dosage Form

Research Article

Austin Chromatogr. 2015;2(2): 1033.

Development of Liquid Chromatographic Method for Estimation of Ondansetron and Ranitidine in Combined Dosage Form

Patel PJ, Shah DA*, Mehta FA and Chhalotiya UK

Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, India

*Corresponding author:Shah DA, Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, India

Received: March 25, 2015; Accepted: May 18, 2015; Published: May 26, 2015

Abstract

Isocratic, reversed phase liquid chromatographic method was developed for the quantitative determination of Ondansetron and Ranitidine in combined dosage form. A Phenomenex Luna C18, 5 μm column with mobile phase containing methanol: water (60:40) was used. The flow rate was 1.0 ml/min and analytes were monitored at 299 nm. The retention times of ondansetron and ranitidine were 9.9 min and 5.5 min, respectively. The linearity for ondansetron and ranitidine were in the range of 0.05-10 μg/ ml and 0.05 - 60 μg/ ml, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity and robustness. Stock solution was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo degradation stability assessment. The method was successfully applied to the estimation of ondansetron and ranitidine in combined dosage form.

Keywords: Ondansetron; Ranitidine; RP-HPLC; Validation; Degradation studies

Abbreviations

OND: Ondansetron; RAN: Ranitidine; LC: Liquid Chromatography

Introduction

Ondansetron (OND) is chemically, 9-Methyl-3-[(2-methyl-1Himidazol- 1-yl) methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one. The empirical formula of OND is C18H19N3 and it has a molecular weight of 293.37g/mole [1], (Figure 1). The OND 5-HT3 Receptor antagonists are the primary drugs used to treat and prevent chemotherapy-induced nausea and vomiting [2]. Ranitidine (RAN)is chemically N-(2-[(5- [(dimethylamino)methyl]furan-2-yl)methylthio]ethyl)-N’-methyl- 2-nitroethene-1,1-diamine; dimethyl [(5-{[(2-{[1-(methylamino)-2- nitroethenyl]amino}ethyl)sulfanyl]methyl}furan-2-yl)methyl]amine. It has an empirical formula of C13H22N4O3S and a molecular weight of 314.4 g/mole [1], (Figure 2). RAN is a histamine-H2 receptor antagonist. RAN is used to reduce the amount of acid secreted by the stomach which subsequently reduces ulcer and heartburn pain. It is used to treat stomach and duodenal ulcer and Gastroesophageal reflux Disease [2]. The clinical study proved that the combination of OND and RAN is effective in reducing the incidence of nausea and vomiting [3].