ANALYTICAL METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF CIPROFLOXACIN HCL AND OLOPATADINE HCL IN BULK DRUG AND FORMULATION BY RP-HPLC METHOD

Abstract

A reverse phase chromatography technique to simultaneously estimate ciprofloxacin HCl and olopatadine HCl as bulk drugs and in formulation has been developed. The chromatographic separation of drugs and formulation was accomplished on C18 Agilent Zorbax column (250 x 4.6 mm, 5 µm) using acetonitrile: TFA water (40:60, V/V). A 10 µL volume was injected with flow rate 1 mL min-1, and peaks were detected. The retention periods for ciprofloxacin HCl and olopatadine HCl were 2.92 and 5.10 minutes respectively. The method was linear in the concentration ranges 24-36 µg mL-1 and 56- 84 µg mL-1 for ciprofloxacin HCl and olopatadine HCl, with regression coefficient correlation values of 0.9999 and 0.9996, respectively. Relative standard deviation of precision, accuracy, and ruggedness was below 2 %. Forced degradation studies were performed under different conditions which were in an admissible range. The established method was simple, accurate, and precise. Therefore, it can be applied for the routine quantification and degradation of these drugs and formulation.