Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CIPROFLOXACIN AND PHENAZOPYRIDINE HYDROCHLORIDE IN COMBINED TABLET DOSAGE FORM

Satishkumar Shetty A, Mohammed Burhan*, Manzoor Ahmed, Anil Kumar S.M., Vijaya Krishna C. Aradhya, and Siddalinga Swamy M.S.

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method and subsequently validate as per ICH guidelines for the determination of Ciprofloxacin (CIP) and Phenazopyridine Hydrochloride (PHENA) using mobile phase [A mixture of methanol and water in the ratio of 80:20 was considered to be the optimal composition] as the solvent. The proposed method involves the measurement of retention Time at selected analytical wavelength. 295.0 nm was selected as the analytical wavelength. The retention time of CIP and PHENA was found to be 4.91 and 2.85 respectively. The linearity of the proposed method was investigated in the range of 5-25 μg/mL (r = 0.9999) for CIP and 10-50 μg/mL (r = 0.9999) for PHENA respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Ciprofloxacin, Phenazopyridine Hydrochloride, Validation.