A New RP-HPLC Method Development and Validation of Sitagliptin in Bulk and Pharmaceutical Dosage Form

Author(s): T.R. Mohapatra*, M. Pati, S.K. Parida and P. Nanda

Abstract: A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Sitagliptin in bulk and pharmaceutical dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column with UV detection at 266 nm and Methanol: Phosphate buffer(pH-4.2) with35:65 ratio at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Sitagliptin in bulk and pharmaceutical dosage form. The method was linear over the range of 0-14μg/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.001 μg/ml and quantification was found to be 0.003 μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.

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