QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form.

ABSTRACT: A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 ​× ​4.6 ​mm, 3.5 ​μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 ​M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The

SUBMITTER: Palakurthi AK 

PROVIDER: S-EPMC7322094 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature