Analytical Method Development and Validation on Liquid Chromatography for Determination of the Drug Cefdinir by Using Tinidazole as an Internal Standard in Bulk and Pharmaceutical Dosage Forms
Gadapa Nirupa, Upendra M. Tripathi
Chemical Science International Journal · pp. 285–296 · Published 17 Dec 2014
10.9734/ACSJ/2015/12275Abstract
The present work involves a rapid and reproducible HPLC method which was developed and validated for the estimation of the drug cefdinir in the bulk drug and pharmaceutical dosage forms. Tinidazole was used as an internal standard. In this method, the estimation was done by using C18 column (100 mm x 4.6 mm, 5 µm); mobile phase consisting of buffer and Methanol (80:20). Buffer was prepared by dissolving 0.025M of Potassium dihydrogen orthophosphate in 1000 ml of water. The pH was adjusted to 2.5 with Orthophosphoric acid; the flow rate of 1.8 mL/min and ultraviolet detection at 290 nm. The retention time of Cefdinir was found to be 2.9 min. The method was partly validated with respect to Precision, Linearity, Accuracy, Ruggedness and Robustness as per ICH guidelines. The validated method was successfully applied to the commercially available pharmaceutical dosage forms.
References (6)
- 1 Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: Method development, optimization, validation, and its application to a pharmacokinetic study [DOI]
- 2 A developed and validated stability-indicating reverse-phase high performance liquid chromatographic method for determination of cefdinir in the presence of its degradation products as per International Conference on Harmonization guidelines [DOI]
- 3 Development and validation of a rapid HPLC method for the determination of cefdinir in beagle dog plasma integrated with an automatic on-line solid-phase extraction following protein precipitation in the 96-well plate format [DOI]
- 4 DEVELOPMENT AND VALIDATION OF A RAPID STABILITY INDICATING CHROMATOGRAPHIC DETERMINATION OF CEFDINIR IN BULK POWDER AND DOSAGE FORM USING MONOLITHIC STATIONARY PHASE [DOI]
- 5 Development and validation of a stability-indicating UHPLC method for assay of felbamate and related substances [DOI]
- 6 A Simple RP?HPLC Method for the Determination of Cefdinir in Human Serum: Validation and Application in a Pharmacokinetic Study with Healthy Bangladeshi Male Volunteers [DOI]
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