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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 9
First page : ( 4035) Last page : ( 4040)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00713.1

Analytical method development and validation of teneligliptin by rp-uflc

Maruthi R1,4, Chandan R.S*, Barath M1, Datta G Naveen2,5, D'silva Merryl2, Kumari M Kajal3, Ahmad Farhan6, Geetha R6

1Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Mysuru

2Department of Pharmaceutics, JSS College of Pharmacy, Mysuru

3Department of Pharmacy Practise, JSS College of Pharmacy, Mysuru

4JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru-Karnataka, India, 570015

5JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru-Karnataka, India, 570015

6JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru-Karnataka, India, 570015

*Corresponding Author E-mail: rschandan@jssuni.edu.in

Online published on 16 September, 2020.

Abstract

To estimate Teneligliptin by Ultra-Fast Liquid Chromatographic (RP-UFLC), a fast, reliable, and cost-effective UFLC method was developed. The approximate flowing rate was 1.0 mL/minfor the Phenomenex Kinetex column C18 (250mmx 4.6mm. 5 Micron) with MeOH and ACN (60:40 v/v) as a portable stream. A PDA detector at 246 nm was used to track the eluent. Teneligliptin elutes at 4.938 minutes of the processing period. The proposed method has a linearity of 10 to 50μg/ml concentration range; the calibration diagram is continuous and 0.9942 percent for the correlations variable (r2). For the suggested procedure, both LOD and LOQ are measured as 0.097 and 1.023μg/mL, respectively. In the pharmaceutical product, the drug has been under the states of stress conditions acidic, alkaline, degradation, Ultraviolet, and heat stress. The degradation product from the Teneligliptin was well solved, and thus the stability of this method was demonstrated. The process was tested in compliance with ICH criteria of device suitability, linearity, reliability, consistency, and robustness.

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Keywords

Teneligliptin, Validation, ICH guidelines, Stability studies.

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