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Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF RANITIDINE,DOMPERIDONE AND SIMETHICONE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC METHOD

P. Satyanarayana*, K. L. N. N. S. V. K. Pavankumar, A. Srinivasa Rao, G. Subrahmanya Sastry

ABSTRACT

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Ranitidine,Domperidone and Simethicone in bulk and pharmaceutical formulations. Separation of Ranitidine, Domperidone and Simethicone was successfully achieved on a Kromasil C8 (250 mm x 4.6mm x 5µ ) in an isocratic mode utilizing 0.1%OPA and methanol (55:45 v/v) at a flow rate of 1.2 mL/min. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 52.5-157.5 mcg/mL for ranitidine and 3.5-10.5 mcg/mL for domperidone and 7-21 mcg/mL for simethicone.The correlation coefficient was found to be 0.999 for both the drugs. The LOD and LOQ for ranitidine were found to be 0.339 µg/mL and 1.130 µg/mL respectively. The LOD and LOQ for domperidone were found to be 0.1156 µg/mL and 0.3852 µg/mL respectively. The LOD and LOQ for simethicone were found to be 0.028 µg/mL and 0.093 µg/mL respectively The proposed method was found to be good percentage recovery for Ranitidine, Domperidone and Simethicone, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Keywords: RP-HPLC, Ranitidine,Domperidone ,Simethicone,Simultaneous Estimation.


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