Development and Validation of RP-HPLC Method for the Estimation of Repaglinide in Bulk Drug and Pharmaceutical Formulation

A new Reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of Repaglinide in bulk drug and pharmaceutical formulations. Optimum separation was achieved in 3 minutes using C18 column (100×4.6) mm×5μ Kromasil ODS and mobile phase was (methanol: phosphate buffer pH 3.0) ratio in gradient flow. Elution was accomplished using a flow rate of (1mL/min). Detection was carried out using a UV detector set at 242 nm. A linear relationship between mean peak area and concentration of Repaglinide was observed in the range 1-5 μg/mL. Intra-day and Inter-day precision, accuracy, robustness and system suitability of the method have been established according to the current ICH guidelines. The developed method was successfully applied to the determination of Repaglinide in pharmaceutical formulations. Accuracy, evaluated by means of the recovery study was found within the range as per the limits. No interference was observed from black as well as placebo. The proposed method was successfully employed for the determination of Repaglinide in various pharmaceutical preparations. The proposed method was found to be simple, precise, accurate, rapid and cost effective for the determination of Repaglinide in pure form and its dosage form.

Author(s):

Pingale P. L., Nandasana P. V

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