DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CLARITHROMYCIN, TINIDAZOLE AND LANSOPRAZOLE IN FIXED DOSE COMBINATIONS

Abstract

New RP-HPLC method was developed for the simultaneous estimation of Clarithromycin, tinidazole and lansoprazole in the fixed dose combination (PYLOKIT by CIPLA). RP-HPLC separation was carried out using Ultisil XB-CN column (250 x 4.6 mm) internal diameter and the packing material having 5µm size) using gradient mobile phase of Potassium dihydrogen phosphate: acetonitrile. 1 mL/min was the flow rate and UV detector at 210 nm wavelength was fixed for detection of the drug. The method validation was done as per ICH guideline and the parameters were included such as accuracy, precision specificity, linearity, and robustness were determined. Retention times for the clarithromycin, tinidazole and lansoprazole were 16.643, 5.493 and 12.940 minutes respectively. RP-HPLC method was a simple, reliable and acceptable and it confirmed that method is suitable for the intended use for routine quality control and assay of drugs. This method is successfully applied for the determination of commercial dosage form preparation. This method is validated as per ICH (International conference on harmonization) Guidelines.