STABILITY INDICATING ASSAY OF TELMISARTAN IN TABLETSAbstract
An accurate, simple, precise, rapid stability-indicating assay method was developed and subsequently validated for the estimation of Telmisartan in API and Tablets. The best separation of the drug was achieved on Kromasil C18 (4.6 × 150 mm, 5 µm) with the mobile phase consisted of mixture of 0.01 M Phosphate buffer (pH: 3) and Acetonitrile in ratio of (40:60%) at flow rate of 2 ml/min, with detection at 226 nm using PDA detector. The retention time was found to be 2.728 min. The method was found to be linear in the range of 10-60 µg/ml with a correlation coefficient (r2) of 0.999. The LOD and LOQ of the method were calculated to be 0.256 and 0.776 µg/ml, respectively. The Precision was estimated by employing repeatability; intra-day and inter-day studies and the results were calculated as %RSD values and were found to be within the acceptable limits. Recovery of the drug was found to be in the range of 97-102%, which establishes the accuracy of the method. Forced degradation studies were conducted under a variety of conditions like acidic, alkali, thermal and oxidative. The stressed samples were analyzed by the developed analytical method, and the degradations in all stressed conditions was ≤ 30 % and within the acceptable limits. The proposed HPLC method is validated on the basis of ICH guidelines.
L. K. Sahu *, S. Si and S. K. Patro
School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan (Deemed to be University), Bhubaneswar, Odisha, India.
14 March 2021
21 May 2021
02 June 2021
01 January 2022