DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR ESTIMATION OF TELMISARTAN IN HUMAN PLASMA
Keywords:Telmisartan, HPLC, Protein precipitation, US-FDA validation
Objective: The present study was aimed to develop a rapid, specific and sensitive method based on high performance liquid chromatographic method was developed for the determination of telmisartan using indapamide as an internal standard.
Methods: The utilization of single step protein precipitation method using methanol as a precipitating agent becomes suitable for analysis of a large number of samples. The developed method was validated as per US-FDA guidelines for telmisartan in human plasma.
Result: An isocratic separation was achieved using Hibar C18 (250 x 4.6 mm, 5 Î¼m) column using 10 mmol ammonium formate solution (pH 4.0)â€“methanol (70:30, v/v) as the mobile phase. Detection was carried out at 275 nm. The method was validated over the range of 0.1â€“1.5 Âµg/ml in human plasma with a regression analysis of 0.996. The percentage recovery of the present method was found to be 94.0â€“99.2 %.
Conclusion: The developed analytical method was found to be rapid, single step, plasma preparation coupled with the simple high-performance liquid chromatography coupled with UV detection (HPLCâ€“UV) isocratic chromatographic apparatus makes the method cost-effective and suitable for analysis of a large number of samples.
Jose A, Wilson D, George M, Thomas RK, Justin A. Comparative study on the beneficial effects of telmisartan and other antihypertensive agents in stroke patients. Int J Pharm Sci 2016;9:99-102.
Anand S, Muniappan M, Sangavi M, Parthiban R. Anti-inflammatory activity of telmisartan and rosuvastatin in the various animal model. Int J Pharm Pharm Sci 2014;6:182-6.
Bhat LR, Godge RK, Vora AT, Damle MC. Validated RP-HPLC method for simultaneous determination of telmisartan and hydrochlorothiazide in pharmaceutical formulation. J Liq Chromatogr Relat Technol 2007;30:3059â€“67.
Rane VP, Sangshetti JN, Shinde DB. Simultaneous high-performance liquid chromatographic determination of telmisartan and hydrochlorothiazide in the pharmaceutical preparation. J Chromatogr Sci 2008;46:887â€“91.
Yan T, Li H, Deng LL, Guo YJ, Yu WS, Fawcett JP, et al. Liquid chromatographic-tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydro-chlorothiazide in human plasma. J Pharm Biomed Anal 2008; 48:1225â€“9.
US Department of Health and Human Services Food and Drug Administration; 2001. Available from: http://www.fda.gov/ cder/guidance/index.htm. [Last accessed on 20 Sep 2018].