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Abstract

A simple, robust, precise UV spectroscopic method for quantitative determination of Linagliptin in bulk and marketed dosage form was developed . In this research work, method involved optimization of experimental conditions such as selection of wavelength, selection of solvent and linearity range. Calibration curve of standard solutions was prepared and various validation parameters were assessed. Linagliptin shows maximum absorbance at ?max 297nm. Linear relationship observed in the range 2-12 µg/ml showing correlation coefficient (r2) 0.9998. The accuracy of methods was assessed by recovery studies and found to be within range 98-102 %. The developed method was validated with respect to precision, linearity, LOD, LOQ, Repeatability. The obtained results were validated as per ICH guidelines. This developed method can be employed for determination of Linagliptin from marketed formulation with no any interference from excipients.

Keywords

Linagliptin, Development, Validation, Absorbance

Reference

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Reshma Dhakate
Corresponding author

Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Lonavala

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Sachin Zende
Co-author

Student, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune.

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Sakshi Renge
Co-author

Student, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune.

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Jaydeep Pawar
Co-author

Student, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune.

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Vikas Pawar
Co-author

Student, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune.

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Nitin Salve
Co-author

Student, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune.

Reshma Dhakate, Sachin Zende, Sakshi Renge, Jaydeep Pawar, Vikas Pawar, Nitin Salve, Development And Validation Of UV Spectroscopy For Determination Of Linagliptin In Bulk And Marketed Dosage Form, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 2, 584-589. https://doi.org/10.5281/zenodo.10688773

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