Abstract

Basant Lal*, Manish Jaimini and Devesh Kapoor

ABSTRACT

New RP-HPLC method was developed for the simultaneous estimation of Clarithromycin, amoxicillin and esomeprazole in the fixed dose combination (PYLOKIT AC 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 5?m 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, amoxicillin and esomeprazole were 16.481, 3.747 and 10.586 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 council on harmonization) Guidelines.