Wed, 22 Nov 2017

Method Development and Validation for the determination of potential impurities present in Telmisartan and Hydrochlorothiazide in fixed dose combination drug product by using Reverse Phase - Ultra Performance Liquid Chromatography coupled with Diode-Array Detector

R. Srikanth Reddy1, R. Murali Krishna2, N.A. Vekaria1, Sumathi V rao1and Bhaskara P.V Mantena1

1.APL Research centre (A division of Aurobindo Pharma Limited), Survey No. 313, Bachupally, Quthubullapur Mandal, Ranga reddy District, Hyderabad, Telangana-500090, India.

2.PNCO Department, Andhra University, Visakhapatnam - 530 003, Andhra Pradesh, India


ABSTRACT

A new selective, sensitive and Rapid Reverse phase-UPLC method was developed and validated to determine the known potential impurities present in Telmisartan (TL) and Hydrochlorothiazide (HC) in fixed dose combination drug product. The quantification was carried out by using Acquity UPLC, HSS T3 (100 × 2.1) mm, 1.8m column, with a flow rate of  0.5mL/min at 225 nm .The mobile phase consists of 0.1% ortho phosphoric acid pH adjusted to 2.6 with diluted sodium hydroxide as Mobile phase A and acetonitrile as Mobile phase B. Separation of the impurities was achieved within 10.0 minutes of run time. Typical retention times of TL and HC were found to be about 5.4 and 2.0 minutes respectively. The product was subjected to various degradation conditions and validated in terms of linearity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines. The known impurities quantified in this study were HC imp-1 to 4 for Hydrochlorothiazide and TL imp-1 to 6 for Telmisartan. Recovery was established for all the impurities with respective to LOQ to 150%. The data supports that the newly developed method is capable to determine all the potential impurities of TL and HC.

Keywords: Telmisartan, Hydrochlorothiazide, Forced Degradation, RP-UPLC and Stability Indicating


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