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Development and validation of first order derivative UV-Spectrophotometric method for determination of Sitagliptin in bulk and in Formulation

Objective: A simple, rapid, accurate and economical First order UV-derivative spectrophotometric method has been developed for estimation of sitagliptin from bulk and pharmaceutical formulation. Materials and methods: The λmax of sitagliptin in methanol and water was found to be 267 nm. The same spectrum was derivatised in to first order derivative; showed maximum amplitude of the trough at 275 nm. The drug follows linearity in the concentration range 10-60 μg/ml with correlation coefficient value 0.998. Results: The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.19 % was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 %. The % recovery was found to be in the range 98.54%– 99.98%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. Conclusion: The above method was a rapid and costeffective quality-control tool for routine analysis of sitagliptin in bulk and in pharmaceutical dosage form

Author(s): Jain Pritam, Chaudhari Amar, Desai Bhargav, Patel Shani, Patel Santsaran, Shimpi Hiren

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