DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF CEFDINIR IN BULK AND CAPSULE DOSAGE FORM

A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Cefdinir in pharmaceutical capsule dosage forms. RP-HPLC method was developed by using Welchrom C18 Column (4.6 X 250mm, 5µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of10mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50v/v).The flow rate was set to 1.0 mL.min -1 with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Cefdinir was found to be 2.523 min. Linearity was established for Cefdinir in the range of 2-10µg.mL -1 with correlation coefficient 0.999. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Cefdinir in pharmaceutical capsule dosage form.