Development and Validation of RP-High Performance Liquid Chromatographic Method for Simultaneous Estimation of Teneligliptin and Pioglitazone In Tablet Formulation
DOI:
https://doi.org/10.22270/ajprd.v12i6.1456Abstract
A reliable, economical, sensitive and reproducible RP-HPLC was developed and validated for the simultaneous estimation of Teneligliptin (TENE) and Pioglitazone (PIO) in combined dosage form. In the RP-HPLC method the mobile phase used was Acetonitrile: 5mM potassium dihydrogen orthophosphate (KH2PO4) buffer (60:40) at PH 3.6 and flow rate was 1.0 ml per min. The method was scanned at isosbestic point 238 nm for both the drugs. The linearity range for TENE and PIO was found to be 0.1-500 µg/ml and 0.500 µg/ml with regression correlation coefficient of (R2) 1.000 and 0.999 respectively. The LOD and LOQ for TENE was found to be 0.002645 and 0.0801 and for PIO was found to be 0.017727 and 0.05371 respectively. The retention time for Teneligliptin andPioglitazone was found to be 2.678 min and 5.010 min respectively. The percentage Assay for TENE and PIO was found to be 97.90-100.69%w/w and 98.53-99.58% w/w respectively. The developed method RP-HPLC was validated as per ICH guidelines.
Downloads
References
Miyako K. Teneligliptin: a DPP-4 inhibitor for the treatment of type 2 diabetes. DiabeticsMetabolic Syndrome Obesity: Targets Therapy 2013; 6:187-95.
Lokhande DP. Analytical method development and validation of teneligliptin by using RP-HPLC with ICH guidelines. Int. J. Trend. Sci. Res. Dev. 2019;3(3):259-66.
Brettenthaler N, De Geyter C, Huber PR, Keller U. Effect of the insulin sensitizer pioglitazone on insulin resistance, hyperandrogenism, and ovulatory dysfunction in women with polycystic ovary syndrome. J. Cli. Endri & Metab. 2004;89(8):3835-40.
Maste MM, Gawas NS, Shashtri U, Shelar P. RP-HPLC Method Development and Validation for Pioglitazone in Bulk and Marketed Formulation. Der Pharma Chemica,2021, 13(6): 6-15.
Vidushi V, Meenakshi B. A review on HPLC method development and validation. RJLBPCS. 2017;2(6):166–78.
Validation of Analytical procedure; Text and methodology Q2 (R1), International Conference on Harmonisation of technical requirements for human use, ICH Harmonized tripartite guidelines, 2005.
Published
How to Cite
Issue
Section
Copyright (c) 2024 Vinay T, Lalitha N, Mubeen G
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.