Development And Validation Of UV Spectroscopy For Determination Of Linagliptin In Bulk And Marketed Dosage Form

Reshma Dhakate, Sachin Zende, Sakshi Renge, Jaydeep Pawar, Vikas Pawar, Nitin Salve,

doi:10.5281/zenodo.10688773

Research Paper | Open Access
Volume 02 | Issue 02 | Article Id IJPS/240202102

Development And Validation Of UV Spectroscopy For Determination Of Linagliptin In Bulk And Marketed Dosage Form
Reshma Dhakate* Sachin Zende Sakshi Renge Jaydeep Pawar Vikas Pawar Nitin Salve
¹Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Lonavala
^2-6Student, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Pune.

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

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Reshma Dhakate

Corresponding author

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