Abstract

DEVELOPMENT AND VALIDATION OF A NOVEL ANALYTICAL METHOD FOR ESTIMATION OF TELMISARTAN IN TABLET DOSAGE FORMS USING HYDROTROPIC SOLUBILIZATION

Pal Tapas Kumar*, Panda Moumita, Roy Chowdhury S

Abstract

The objective of the present work was to explore the application of a hydrotropic solubilization phenomenon in the quantitative analysis of a model poorly water soluble (BCS Class II) drug. Other part of study was to develop and validate simple, easy, cost effective, eco-friendly unique spectrophotometric method of analysis for the novel poorly water soluble drug, Telmisartan, in pure and tablet dosage forms, utilizing the principle of single hydrotropic solubilization involving 20(M) Urea and 2(M) Sodium Benzoate. Solubility of Telmisartan in distilled water and each of the hydrotropes were determined and compared. The percentage label claims of Telmisartan in bulk and tablet forms were estimated by this novel spectrophotometric method. This method was validated for accuracy, linearity, precision, specificity and robustness as per recommendations in official guidelines. The study results revealed that the solubility of Telmisartan had been enhanced by more than 19 times in 20 (M) Urea and 11 times in 2(M) Sodium Benzoate respectively. The standard calibration curves were found obeying Beer-Lambert’s principles as well as linearity at concentration range of 5 - 20 μg/ml (R2 = 1 and % RSD < 2 both intra- and inter-day precision). Analysis of commercial tablets were found to contain drug content well within specified official label claim, (100.53% - 102.95%) of Telmisartan utilizing both the hydrotropes; while per cent recoveries in both the hydrotropes were found ranging from (100.13%-103.73%) - which was well within the specified official limit (90.0%-110%) of Pharmacoepoeal monograph of Telmisartan tablets (ref. USP 2011), even comparable to official HPLC method of analysis. %RSD and %CV were calculated and found < 2 with low standard error. LOD and LOQ were 0.575, 1.745 and 0.406, 1.231 in Urea and Sodium Benzoate respectively. In this assay method, there was no significant interference from any common pharmaceutical additives and diluents. The developed analytical method was proved as simple, specific, selective, reproducible, robust and validated for routine analysis of Telmisartan in pure and tablet dosage forms even without using costly and harmful organic solvents.

Keywords: Angiotensin, ARB, BCS Class II, hydrotrope, LOD, LOQ, label claim.