STABILITY-INDICATING RP-UHPLC METHOD FOR DETERMINATION OF TELMISARTAN IN DRUG SUBSTANCE AND MARKETED FORMULATIONAbstract
A simple, rapid and precise stability-indicating ultra high performance liquid chromatography (UHPLC) has been developed and validated for the estimation of telmisartan in drug substance and pharmaceutical dosage form. The chromatographic separation was achieved with a Poroshell 120EC-C18 column (4.6 x 50mm, 2.7µm) by using mobile phase acetonitrile: 50mM ammonium acetate buffer in the ratio of (45: 55 v/v), pH adjusted to 4.5 with acetic acid. The instrumental settings were flow rate of 0.5ml min-1, column temperature at 25 0C and detector wavelength of 290 nm using a photodiode array detector. Telmisartan was exposed to thermolytic, photolytic, acid, base, hydrolytic and oxidative stress conditions and the stressed samples were analyzed by the proposed method. The developed method shows excellent linearity over a range of 100-300 µg ml-1 for telmisartan. The recovery of telmisartan was above 96%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of telmisartan pharmaceutical preparations.
Biswa Ranjan Patra*, S. Mohan and Nagaraj Gowda
Department of Pharmaceutical Analysis, PES college of Pharmacy, Bengaluru, Karnataka, India.
30 November, 2015
09 February, 2016
19 March, 2016
01 May 2016