Volume : 10, Issue : 03, March – 2023



Authors :

Dara Rakesh, M. Ashok Babu

Abstract :

Analytical Method Development and Validation for Telmisartan and Amlodipine in Tablet Dosage Form by RP-HPLC. New method was established for simultaneous estimation of Telmisartan and Amlodipine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Telmisartan and Amlodipine by using Inertsil C18 (4.6mm ×250mm, 5µm particle size), flow rate was 1.0 ml/min, mobile phase ratio was (55:45% v/v) Methanol: Phosphate buffer pH 4.8 (pH was adjusted with ortho phosphoricacid), detection wavelength was 282nm. The instrument used was WATERS Alliance 2695 separation module, Software: Empower 2, 996 PDA detector. The retention times were found to be 1.688mins and 3.282mins. The % purity of Telmisartan and Amlodipine was found to be 99.86%. The system suitability parameters for Telmisartan and Amlodipine such as theoretical plates and tailing factor were found to be 7586, 1.69 and 6235 and 1.58, the resolution was found to be 10.85. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Telmisartan and Amlodipine was found in concentration range of 100µg-500µg and 30µg-70µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.112% and 100.16%, %RSD for repeatability was 0.1702 and 0.043 respectively. The precision study was precise, robust, and repeatable. The LOD value was found to be 2.1µg/ml and 1.28µg/ml, and LOQ value was 6.3µg/ml and 3.84µg/ml for Telmisartan and Amlodipine respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Telmisartan and Amlodipine in Tablet dosage form.
Keywords: Telmisartan and Amlodipine, Method Development, Validation, Accuracy, Precision.

Cite This Article:

cite this article in press Dara Rakesh et al, Development And Validation Of A Novel RP-HPLC Method For Simultaneous Determination Of Telmisartan And Amlodipine In Tablet Formulation., Indo Am. J. P. Sci, 2023; 10 (03).

Number of Downloads : 10


1. Karlberg BE, Lins LE, Hermansson K: Efficacy and safety of telmisartan, a selective AT1 receptor antagonist, compared with enalapril in elderly patients with primary hypertension. TEES Study Group. J Hypertens. 1999 Feb;17(2):293-302.
2. Balt JC, Mathy MJ, Nap A, Pfaffendorf M, van Zwieten PA: Effect of the AT1-receptor antagonists losartan, irbesartan, and telmisartan on angiotensin II-induced facilitation of sympathetic neurotransmission in the rat mesenteric artery. J Cardiovasc Pharmacol. 2001 Jul;38(1):141-8.
3. Meredith PA, Elliott HL: Clinical pharmacokinetics of amlodipine. Clin Pharmacokinet. 1992 Jan;22(1):22-31.
4. Fares H, DiNicolantonio JJ, O’Keefe JH, Lavie CJ: Amlodipine in hypertension: a first-line agent with efficacy for improving blood pressure and patient outcomes. Open Heart. 2016 Sep 28;3(2)
5. Malesuik MD, Cardoso SG, Bajerski L, Lanzanova FA. Determination of amlodipine in pharmaceutical dosage forms by liquid chromatography and ultraviolet spectrophotometry. J AOAC Int. 2006;89:359–364. [PubMed] [Google Scholar]
6. Lima DM, Dos Santos LD, Lima EM. Stability and in vitro release profile of enalapril maleate from different commercially available tablets: possible therapeutic implications. J Pharm Biomed Anal. 2008;47:934–937. [PubMed] [Google Scholar]
7. Bhardwaj SP, Singh S. Study of forced degradation behavior of enalapril maleate by LC and LC-MS and development of a validated stability-indicating assay method. J Pharm Biomed Anal. 2008;46:113–120. [PubMed] [Google Scholar]
8. Naidu KR, Kale UN. Stability indicating UPLC method for simultaneus determination of amlodipine and benazepril hydrochloride from their combination drug product. J Pharm Biomed Anal. 2005;39:147–155. [PubMed] [Google Scholar]
9. Kurbanoglu S, Gumustas M, Uslu B, Ozkan SA. A sensitive and selective RP-LC method for the simultaneous determination of the antihypertensive drugs, enalapril, lercandipine, nitrendipine and their validation. Chromatographia. 2013;76:1477–1485. [Google Scholar]
10. Al-Mahmud A, Bhadra S, Haque A, Al-Mamun E, Haider SS. Development and validation of HPLC method for simultaneous determination of gliclazide and enalapril maleate in tablet dosage form. Dhaka Uni J Pharm Sci. 2014;13:51–56. [Google Scholar]
11. Wankhede SB, Wadkar SB, Raka KC, Chitlange SS. Simultaneous estimation of amlodipine besylate and olmesartan medoxomil in pharmaceutical dosage form. Ind J Pharm Sci. 2009;71:563–567. [PMC free article] [PubMed] [Google Scholar]
12. Sharma M, Kothari C, Sherikar O, Mehta PJ. Concurrent estimation of amlodipine besylate, hydrochlorothiazide and Enalapril maleate by UPLC, HPTLC and UV spectrophotometry. J Chromatogr Sci. 2013;52:27–35. [PubMed] [Google Scholar]
13. Elsebaei F, Zhu Y. Fast gradient high performance liquid chromatography method with UV detection for simultaneous determination of seven angiotensin converting enzyme inhibitors together with hydrochlorothiazide in pharmaceutical dosage forms and spiked human plasma and urine. Talanta. 2011;85:123–129. [PubMed] [Google Scholar]