DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR ESTIMATION OF TELMISARTAN IN HUMAN PLASMA
DOI:
https://doi.org/10.22159/ijap.2019v11i1.30513Keywords:
Telmisartan, HPLC, Protein precipitation, US-FDA validationAbstract
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 μm) column using 10 mmol ammonium formate solution (pH 4.0)–methanol (70:30, v/v) as the mobile phase. Detection was carried out at 275 nm. The method was validated over the range of 0.1–1.5 µg/ml in human plasma with a regression analysis of 0.996. The percentage recovery of the present method was found to be 94.0–99.2 %.
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 (HPLC–UV) isocratic chromatographic apparatus makes the method cost-effective and suitable for analysis of a large number of samples.
Downloads
References
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;30:3059–67.
Rane VP, Sangshetti JN, Shinde DB. Simultaneous high-performance liquid chromatographic determination of telmisartan and hydrochlorothiazide in the pharmaceutical preparation. J Chromatogr Sci 2008;46:887–91.
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; 48:1225–9.
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].
Published
How to Cite
Issue
Section
