Analytical Method Development and Validation onLiquid Chromatography for Determination of theDrug Cefdinir by Using Tinidazole as an InternalStandard in Bulk and Pharmaceutical Dosage Forms

摘要

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.