Abstract

“RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR AZITHROMYCIN AND CEFPODOXIME IN TABLET DOSAGE FORM.”

Shaikh Javed Shaikh Afzal*, Dr. Pathan Mohd Arif Ali Khan and Mirza Shahed Baig

ABSTRACT

A simple, rapid and accurate reversed phase high-performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous determination of Azithromycin (AZT) and Cefpodoxime(CEF) in pharmaceutical dosage form. The HPLC analysis was performed on the Hypurity C18 column (100 mm x 4.6 mm id, 5 μm particle size) in isocratic mode, at 30°C temperature using a mobile phase consisting of methanol: Toluene: 100mMpotassium dihydrogen phosphate buffer (60:30:10, v/v/v) at a flow rate of 1 mL/min. The detection was carried out at 218 nm for Azithromycin and Cefpodoxime. The retention time for Azithromycin and Cefpodoxime were found to be 5.20 min and 2.91min, respectively. The method was validated for precision, recovery, robustness, specificity and detection and quantification limits, in accordance with ICH Q2R1 guidelines. Linearity was observed in the concentration range from 5.00-30.00 μg/mL (r2=0.99) for both Azithromycin and Cefpodoxime (r2=0.99), the limit of detection and quantification of AZT were 0.250 μg/mL and 0.320 μg/mL, respectively. While for CEF it was 0.320 μg/mL and 0.700 μg/mL, respectively. The % recovery was found to be within 99-100% for Azithromycin and 99-100% for Cefpodoxime. The % RSD below 2.0 showed the high precision of proposed method.

Keywords: Azithromycin, Cefpodoxime, high performance liquid chromatography and validation.