Asian Journal of Pharmaceutical Analysis

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Telmisartan, Amlodipine Besylate and Hydrochlorthiazide in their Tablet Dosage Form


Affiliations
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, India
     

   Subscribe/Renew Journal


To treat the second stage high blood pressure, physicians prefers the combination drug therapy consisting of two or more anti-hypertensive agents. Among these, telmisartan with amlodipine besylate, telmisartan with hydrochlorthiazide as well as triple drug therapy consisting of amlodipine besylate, telmisartan and hydrochlorthiazide are commonly prescribed. In the present paper, a simple, accurate and precise RP-HPLC method was developed for the estimation of amlodipine besylate, telmisartan and hydrochlorthiazide in bulk and combined dosage form. All these three drugs were successfully separated and resolved from each other on C18 kinetex column (250 × 4.6 mm, 5 μ), using acetonitrile: 20mM phosphate buffer (pH 3.0) (60:40 %, v/v) as a mobile phase at a flow rate of 1 mL/min. The detection was performed at 258 nm. The developed method was further validated as per ICH Q2 (R1) guidelines.

Keywords

Telmisartan, Amlodipine Besylate, Hydrochlorthiazide, RP-HPLC, Analytical Method Validation.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Wan, X., P. Ma, and X. Zhang, A promising choice in hypertension treatment: Fixed-dose combinations. Asian Journal of Pharmaceutical Sciences, 2014,9(1): p. 1-7.

  • Kondawar, M., et al., UV spectrophotometric estimation of amlodipine besylate and telmisartan in bulk drug and dosage form by multiwavelength analysis. Int. J Chem Tech Res, 2011. 3: p.1274-8.

  • Kranthi, M. and A. Srinivas, Analytical Method Development and Validation and Force Degradation Studies for Simultaneous Estimation of Amlodipine Besylate and Telmisartan in Tablet Dosage Form by using RP-HPLC. International Journal of Pharmaceutical and Phytopharmacological Research, 2017,4(1): p.2-7.

  • Thomas, A.B., et al., Simultaneous spectrophotometric estimation of amlodipine besylate and telmisartan in tablet dosage form. Int J Pharm Tech Res, 2010, 2: p. 1334-1341.

  • Vekariya, N., et al., Application of TLC-densitometry method for simultaneous estimation of telmisartan and amlodipine besylate in pharmaceutical dosage form. Int. J. Pharm. Res, 2009, 1(4): p.1644-1649.

  • Shah, N., et al., Development and validation of a HPTLC method for the simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form. Indian Journal of Pharmaceutical Sciences, 2007,69(2): p. 202.

  • Wankhede, S.B., et al., RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form. Indian journal of pharmaceutical sciences, 2007, 69(2): p.298.

  • Gangola, R., S. Kaushik, and P. Sharma, Spectrophotometric simultaneous determination of hydrochlorothiazide and telmisartan in combined dosage form. Journal of Applied Pharmaceutical Science, 2011, 1(1): p. 46.

  • Kavitha, J., et al., Development and validation of RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorothiazide in tablets: its application to routine quality control analysis. Int J Pharm Pharm Sci, 2011, 3: p. 113-5.

  • Rane, V., J. Sangshetti, and D. Shinde, Simultaneous highperformance liquid chromatographic determination of telmisartan and hydrochlorothiazide in pharmaceutical preparation. Journal of Chromatographic Science, 2008. 46(10): p. 887-891.

  • Bhatia, N., et al., Development and validation of spectrophotometric and ion pair chromatographic techniques for estimation of telmisartan and hydrochlorothiazide. 2010.

  • Maheswari, R., et al., Simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form by HPTLC method.Asian Journal of Chemistry, 2007, 19(7): p. 5582.

  • Nalwade, S., et al., Rapid simultaneous determination of telmisartan, amlodipine besylate and hydrochlorothiazide in a combined poly pill dosage form by stability-indicating ultraperformance liquid chromatography. Scientia Pharmaceutica, 2011, 79(1): p. 69-84.

  • Sinojiya, R.S., et al., Development and Validation of RP-HPLC Method for the Simultaneous Determination of Telmisartan, Amlodipine Besylate and Hydrochlorothiazide in a Tablet Dosage Form. Journal of Pharmacy Research Vol, 2012,5(8): p. 41544157.

  • Mhaske, R., et al., RP-HPLC method for simultaneous determination of amlodipine Besylate, Valsartan, Telmisartan, Hydrochlorothiazide and Chlorthalidone: application to commercially available drug products. International Journal of Pharmaceutical Sciences and Research, 2012,3(1): p. 141.

  • Validation of Analytical Procedures: Text and Methodology, Q2R1, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonized Triplicate Guidelines 2005.


Abstract Views: 334

PDF Views: 0




  • Development and Validation of RP-HPLC Method for Simultaneous Estimation of Telmisartan, Amlodipine Besylate and Hydrochlorthiazide in their Tablet Dosage Form

Abstract Views: 334  |  PDF Views: 0

Authors

Ashwini Parmar
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, India
Sandeep Sonawane
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, India
Santosh Chhajed
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, India
Sanjay Kshirsagar
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, India

Abstract


To treat the second stage high blood pressure, physicians prefers the combination drug therapy consisting of two or more anti-hypertensive agents. Among these, telmisartan with amlodipine besylate, telmisartan with hydrochlorthiazide as well as triple drug therapy consisting of amlodipine besylate, telmisartan and hydrochlorthiazide are commonly prescribed. In the present paper, a simple, accurate and precise RP-HPLC method was developed for the estimation of amlodipine besylate, telmisartan and hydrochlorthiazide in bulk and combined dosage form. All these three drugs were successfully separated and resolved from each other on C18 kinetex column (250 × 4.6 mm, 5 μ), using acetonitrile: 20mM phosphate buffer (pH 3.0) (60:40 %, v/v) as a mobile phase at a flow rate of 1 mL/min. The detection was performed at 258 nm. The developed method was further validated as per ICH Q2 (R1) guidelines.

Keywords


Telmisartan, Amlodipine Besylate, Hydrochlorthiazide, RP-HPLC, Analytical Method Validation.

References