Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AZITHROMYCIN AND CEFPODOXIME PROXETIL IN COMBINED TABLET DOSAGE FORM.

Vijaya krishna.C.Aradhya, Ranjitha L.R*, Satishkumar Shetty.A, Manzoor Ahmed, Anil Kumar.S.M, Kuppast I.J.

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Azithromycin (AZI) and Cefpodoxime Proxetil (CEF) using mobile phase [A mixture of acetonitrile and Phosphate buffer- pH-7.0 in the ratio of 65:35 was considered to be the optimal composition] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 270.0 nm was selected as the analytical wavelength. The retention time of AZI and CEF was found to be 7.318 and 3.521 respectively. The linearity of the proposed method was investigated in the range of 10-50 μg/ml (r = 0.9999) for AZI and 8-40 μg/ml (r = 0.9998) for CEF 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, Azithromycin, Cefpodoxime Proxetil, Validation.