Method Development and Validation of Reverse Phase High Performance Liquid Chromatography Method for Estimation of Ondansetron and Pantoprazole in their Tablet Dosage Form
Department of Pharmaceutical Analysis, Vignan Institute of Pharmaceutical Sciences, Hyderabad, Telangana 508284, 1Department of Pharmaceutical Analysis, Chaitanya College of Pharmacy Education and Research, Warangal, Telangana 506001, India
G. K. Rakam, Department of Pharmaceutical Analysis, Vignan Institute of Pharmaceutical Sciences, Hyderabad, Telangana 508284, India, E-mail: email@example.com
The objective of the study was to develop reverse phase high performance liquid chromatography method for the determination of purity of ondansetron and pantoprazole in tablet form. A reverse phase high performance liquid chromatography method was developed for the estimation of ondansetron and Pantoprazole in tablet formulation. The current method consists of different mobile phase compositions and it is a new approach for the estimation of selected drugs in quality control laboratory, which is novel to the market and for better illusion, buffer was used in the present method. Chromatographic separation of the drug was achieved on a Phenomenex Kromosil C-18, 5 μm, column (250×4.6 mm) using a mobile phase of methanol: Acetonitrile: Potassium hydrogen ortho phosphate buffer pH 3 (40:20:40 v/v) at a flow rate of 1 ml/min. The drug eluted was monitored at 210 nm and the retention time of ondansetron and pantoprazole was found to be 2.7 and 4.l min respectively. The calibration curve was linear over the range of 20-120 μg/ml. The correlation coefficient was found to be 0.999 and 0.998 for ondansetron and pantoprazole respectively. The limit of detection and limit of quantification were found to be 0.075 μg/ml and 0.232 μg/ml for ondansetron and 0.063 and 0.219 for pantoprazole which was within the acceptance range. Forced degradation was carried out under various stress conditions to demonstrate the stabilityindicating capability of the developed reverse phase high performance liquid chromatography method. The performance of the method was validated according to International Council for Harmonization guidelines. The proposed method was found to be simple, precise, accurate and validated according to the International Council for Harmonization guidelines.