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

Reference

Jain PS, Chaudhari AJ, Patel SA, Patel ZN, Patel DT. Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation. Pharm Methods. 2011;2(3):198-202
Sharma Shivani, Goyal Swapnil, Chauhan, Kalindi. A review on analytical method development and validation. International Journal of Applied Pharmaceutics. 2018;10(6):8-15
Sujan Banik, MD Masud Kaisar, Mohammad Salim Hossain. Development and Validation of a Simple and Rapid UV Spectrophotometer Method for Assay of Linagliptin in Bulk and Marketed Dosage Form. Indian Journal of Novel Drug Delivery. 2013;5(4):221-224
Rane SS, Chaudhari RY, Patil VR, Barde LG, Development and validation of UV spectrophotometric method for simultaneous estimation of Empagliflozin and Linagliptin in bulk drugs and pharmaceutical dosage form, DIMPSIJ. 2021; 01(01):44-54
Avinash C, Gandhimathi R. Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC. International Journal of Pharmaceutical Quality Assurance. 2023;14(1):203-207
Mishra AK, Kumar A, Mishra A, Mishra HV. Development of ultraviolet spectroscopic method for the estimation of metronidazole benzoate from pharmaceutical formulation. J Nat Sci Biol Med. 2014;5(2):261-264.
ICH Tripartite Guideline Q2 (R1), Validation of analytical procedures: text and methodology. International Conference on Harmonization (ICH), Geneva, Nov 2005.
Amruta Dalal, Varsha Tegeli, Rajashri Waghmode. Development and Validation of a Simple and Rapid UV Spectrophotometric Method for Linagliptin in bulk and marketed dosage form. Der Pharma Chemica. 2021;4(2):23-26
Govind Verma and Manisha Mishra. Development and optimization of UV-Vis spectroscopy-a Review. World J. Pharm. Res. 2018;7(11):1170-1180.
Manish Mishra, Govinda Verma. Analytical method development and validation for determination of Linagliptin in bulk and dosage form by UV spectroscopy. Journal of Emerging Technologies and Innovative Research. 2018;7(11):908-912.

Reshma Dhakate

Corresponding author

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