薬学および生命科学における研究開発の国際ジャーナル

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DEVOLPMENT AND VALIDATION OF SIMPLE STABILITY INDICATING RP-HPLC METHOD FOR ANALYSIS OF SAXAGLIPTIN AND ITS FORCED DEGRADATION IMPURITIES IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Pawanjeet.j.chhabda, M. Balaji, Srinivasarao.V, K.Ramakrishna, K. M. Ch. Apparao

The objective of the present research work is developing a gradient, reversed phase liquid chromatographic method for the determination of saxagliptin hydrochloride in bulk drugs and pharmaceutical dosage form. The chromatographic separation was achieved on a Inertsil C8 (4.6x250) mm, 5 μm column, the gradient LC method employs solution A and B as mobile phase. The solution A contains (1.20g of sodium dihydrogen phosphate in 1000 ml of water) pH 5.0 solution B (acetonitrile) at flow rate 1.2 ml/min. The UV detector was operated at 210 nm and temperature was 25�?�?c. The retention time was 7.68 min and linearity was observed in the concentration range of 50-375 μg/ml with correlation coefficient of 0.9999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The method was successfully validated as per International Conference on Harmonization (ICH) guidelines. Saxagliptin hydrochloride undergoes degradation under acidic, basic, oxidation, dry heat and photolytic conditions, degradation impurities did not interfere with the retention time of Saxagliptin hydrochloride. The proposed method was found to be a new, simple, precise, linear, accurate, specific and stability indicating.