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Asian Journal of Pharmaceutical Analysis
Year : 2020, Volume : 10, Issue : 1
First page : ( 11) Last page : ( 14)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2020.00003.4

Development and Validation of an Analytical Method for the Estimation of Metformin and Teneligliptin in its Bulk and Tablet Dosage Form by using RP-HPLC

Bichala Prem Kumar1,*, Kumar K. Jeevan2, Suthakaran R.3, Shankar Ch.3

1Associate Professor, Department of Pharmaceutical Analysis, Vijaya College of Pharmacy, Munaganoor-501511, Hyderabad, Telangana, India

2Department of Pharmaceutical Analysis, Vijaya College of Pharmacy, Munaganoor-501511, Hyderabad, Telangana, India

3Department of Pharmaceutical Analysis, Vijaya College of Pharmacy, Munaganoor-501511, Hyderabad, Telangana, India

*Corresponding Author E-mail: prembichala@gmail.com

Online published on 3 June, 2020.

Abstract

Teneligliptin in tablet dosage form, using Column Inertsil ODS column C8 (4.6 x 250mm), 5μm particle size, mobile phase Phosphate buffer (PH-3): Acetonitrile (50: 50) v/v, detection wavelength at 240nm, at flow rate of 1.0ml/min and the retention time 3.608 and 5.148 min. The correlation coefficient was found to be 0.999 for both the drugs. The Recovery studies were performed for Metformin and Teneligliptin in the range of 50%-150%. The % recovery of Metformin and Teneligliptin found to be 99.97 and 100.64 respectively. % RSD for Precision studies of Metformin and Teneligliptin was found to be 0.4 and 0.8. Forced Degradation studies were conducted according to the ICH guidelines and the Drug Product was found to be stable in all conditions. Hence we recommend that this method can be a good approach for the quantification of Metformin and Teneligliptin in combination dosage form and can be adopted for the routine quality control analysis of these drugs.

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Keywords

Metformin and Teneligliptin, RP-HPLC, ICH.

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