Determination of Telmisartan and Forced Degradation Behavior by Rp-HPLC in Tablet Dosage Form

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of Telmisartan (TELM) in tablet dosage form was developed and validated. Chromatographic separation was achieved on a 250 × 4.6 mm, 5µ, Waters symmetry column in gradient mode, with mobile phase consisting of a mixture of solution (10 mM potassium dihydrogen phosphate, pH 3.5 ± 0.01): acetonitrile (64:40) was used. The quantitation performed at flow rate of 1.0 mL/min at 230 nm and run time was 12 min. The analytical method was validated as per ICH guideline for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness and stability and method can be extended to the analysis of TELM in tablet formulations. The relative standard deviation values for precision was less than 2%, and % recovery was greater than 98% for TELM. The drug undergoes oxidative degradation, thermal degradation and in alkali medium.

Development and Validation of a Stability Indicating HPTLC Method for Simultaneous Estimation of Telmisartan and Gallic Acid as per ICH Q1A (R2)

“…As per literature review, many published data were found regarding forced degradation of TEL alone by UV, 21 HPLC 22,23 and simultaneous estimation of TEL along with other class of antihypertensive drugs, 24,25 diuretics. 26 Very few numbers of papers are available, that utilizes HPTLC method for the estimation of TEL.…”

Stability Indicating Simultaneous Validation of Telmisartan and Cilnidipine with Forced Degradation Behavior Study by RP-HPLC in Tablet Dosage Form

“…It is a diabetes angiotensin receptor blocker that shows high affinity for the angiotensin II type 1 (AT1) receptors, has a long duration of action, and has the longest half-life of any angiotensin II receptor blocker (ARB) [1]. In clinical studies, Telmisartan shows comparable antihypertensive activity to other major antihypertensive classes, such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and calcium antagonists [2].…”

Normal and Reversed-Phase HPTLC Methods for Simultaneous Estimation of Telmisartan and Metoprolol Succinate in Pharmaceutical Formulation

“…TELMI blocks the vasoconstrictor and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland [2,3]. TELMI has been estimated by various methods like spectrophotometric [4], HPLC [5,6], HPTLC [7][8][9][10], and LC-MS [11,12] in pharmaceutical formulations and biological fluids.…”