Development and Validation of Rp- Hplc Method for the Estimation of Repaglinide in Bulk and Tablet Dosage FORM

DHIRENDER SINGH; PRADEEP KUMAR; PRAVESH KUMAR

Volume : II, Issue : VIII, August - 2013

Development and Validation of Rp- Hplc Method for the Estimation of Repaglinide in Bulk and Tablet Dosage FORM

Dhirender Singh, Pradeep Kumar, Pravesh Kumar

Abstract :

A simple reversed–phase high–performance liquid chromatographic (RP–HPLC) method has been developed and validated of repaglinide in bulk and tablet dosage form. Chromatographic analysis was performed on a C18 column (250x 4.6 mm, 5�m) with a mixture of Acetonitrile: Ammonium formate in the ratio 65:35 as mobile phase, at a flow rate of 1.0 mL min−1. UV detection was performed at 245nm. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The retention times of repaglinide were 4.220.0123 respectively. Caliation plots were linear over the concentration ranges 1–6 μg mL−1 for repaglinide with correlation coefficient ¬¬¬¬ (r2) 0.9996 respectively. The Limit of detection was 0.057 and the quantification limit 0.192 +g/ml for repaglinide respectively. The accuracy of the proposed method was determined by recovery studies and found to be 99.72% to 100.33%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of repaglinide and in bulk and tablet dosage form