Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NORFLOXACIN,TINIDAZOLE AND LOPERAMIDE IN BULK AND PHARMACEUTICAL FORMULATIONS USING RP-HPLC METHOD

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

ABSTRACT

A simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Norfloxacin, Tinidazole and Loperamide in bulk and pharmaceutical formulations. Separation of Norfloxacin, Tinidazole and Loperamide was successfully achieved on a BDS Hypersil C18 (250 mm x 4.6mm x 5µ ) in an isocratic mode utilizing Potassium dihydrogen phosphate buffer and methanol (60:40 v/v) at a flow rate of 1.0 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 40-120 mcg/mL for norfloxacin and 60-180 mcg/mL for tinidazole and 0.2-0.6 mcg/mL for loperamide. The correlation coefficient was found to be 0.999 for both the drugs. The LOD and LOQ for norfloxacin were found to be 0.052 µg/mL and 0.172 µg/mL respectively. The LOD and LOQ for tinidazole were found to be 0.3482 µg/mL and 1.1605 µg/mL respectively. The LOD and LOQ for loperamide were found to be 0.001 µg/mL and 0.003 µg/mL respectively The proposed method was found to be good percentage recovery for Norfloxacin, Tinidazole and Loperamide, 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, Norfloxacin, Tinidazole, Loperamide, Simultaneous Estimation.