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DEVELOPMENT AND METHOD VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION OF CEFOPERAZONE AND TAZOBACTAM IN BULK AND PHARMACEUTICAL DOSAGE FORM
- Publication Year :
- 2018
- Publisher :
- Zenodo, 2018.
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Abstract
- Objective: A new precise, accurate, sensitive and robust reverse phase high performance liquid chromatography (RP-HPLC) method was developed for Cefoperazone and Tazobactam in marketed preparation. Method: The Chromatographic separation was achieved on Thermo BDS Hypersil C18 column (250 × 4.6 mm i.d.5 μ) at ambient temperature. A Binary mobile phase consisting of 10 mM potassium dihydrogen phosphate buffer, pH 2.8 and Acetonitrile (80:20, v/v) was delivered through a column at a flow rate of 1 ml/min. Estimation was performed at a coveted wavelength of 254 nm. Result: The method was linear over the concentration range of 40-200 μg/ml and correlation coefficient (r2) was found to be 0.9997 for Cefoperazone (CEFO) and 5-25 μg/ml for Tazobactam (TAZO), correlation coefficient was found to be 0.9996. The retention times of the CEFO and TAZO were found to be 3.667 min and 4.737 min. respectively. The percentage content for Cefoperazone 98.94±1.0 and of Tazobactam was 99.69±0.96 in the marketed formulation. The low value of % Relative Standard Deviation (%RSD) was 0.224 and 0.018 for Cefoperazone and Tazobactam, respectively, indicates the reproducibility of this method. The low value of Limit of detection (LOD) and Limit of quantitation (LOQ) suggests the sensitiveness of method. Conclusion: It can be concluded from the outcomes that the proposed RP-HPLC method was found to be simple, basic, accurate, robust and precise for the normal analysis of Cefoperazone and Tazobactam in bulk and sterile dried injection dosage forms. This method was validated as per ICH guidelines.
- Subjects :
- Cefoperazone, Tazobactam, Validation, RP- HPLC, Forced Degradation Studies
Subjects
Details
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....524138beec9e48de44ca339c39289bba
- Full Text :
- https://doi.org/10.5281/zenodo.2531224