Stability indicating analytical method development and validation for estimation of Ceftazidime and Avibactam in bulk and pharmaceutical dosage form using RP-HPLC


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2

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1

Abstract :

A new simple, rapid, specific, accurate and precise stability indicatind RP-HPLC method has been developed for the estimation of Ceftazidime and Avibactam in bulk & pharmaceutical dosage form. From UV spectrophotometric method selected wavelength for estimation of drugs were 231 nm as isobestic point and 256 nm, 210 nm as λ max of CAZ and AVY respectively by using methanol as a solvent. RP-HPLC method was developed by using Hypersil ODS (150×4.6mm) 5µ. The samples were analyzed by using mixed phosphate buffer (PH adjusted to 4 using orthophosphoric acid): Acetonitrile (60:40 % v/v) as the mobile phase at the flow rate of 1.0 ml/min and detection wavelength is 231 nm. Both the drugs were eluted within 5 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Ceftazidime and Avibactam was found to be 2.523 and 4.410 min respectively. Calibration curve was linear with correlation coefiicient of 0.996 and 0.999 over a concentration range of 240-560 µg/ml and 60-120 µg/ml for Ceftazidime and Avibactam respectively. The percent recovery was 100.10 and 99.75 for Ceftazidime and Avibactam respectively indicating accuracy and reliability of the method. Forced degradation studies were carried out and drug peaks were well resolved without any significant degradation products when subjected to stress conditions. So the developed stability indicating method could be utilized for routine analysis of Ceftazidime and Avibactam in bulk and pharmaceutical dosage form.
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