, 67:575 | Cite as

A Stability-Indicating LC Method for the Simultaneous Determination of Telmisartan and Ramipril in Dosage Form

  • Kiran R. Patil
  • Vipul P. Rane
  • Jaiprakash N. Sangshetti
  • Devanand B. Shinde


A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of telmisartan and ramipril in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with an ACE 5 C18, 25-cm analytical column using buffer–acetonitrile (55:45 v/v). The buffer used in mobile phase contains 0.1 M sodium perchlorate monohydrate in double distilled water pH adjusted 3.0 with trifluoroacetic acid. The instrumental settings are flow rate of 1.5 mL min−1, column temperature at 30 °C, and detector wavelength of 215 nm using a photodiode array detector. The resolution between ramipril and telmisartan were found to be more than 5. Theoretical plates for ramipril and telmisartan were 13,022 and 6,629. Tailing factor for ramipril and telmisartan was 0.94 and 0.98. Telmisartan, ramipril and their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of telmisartan and ramipril is obtained using photodiode array detector, in the stressed sample chromatograms, demonstrated the specificity of the method for their estimation in presence of degradants. The described method shows excellent linearity over a range of 20–400 μg mL−1 for telmisartan and 2.5–50 μg mL−1 for ramipril. The correlation coefficient for telmisartan and ramipril are 1. The relative standard deviation for six measurements in two sets of each drug in tablets was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of telmisartan and ramipril in pharmaceutical preparations.


Column liquid chromatography Method validation Pharmaceutical preparation Ramipril and telmisartan 



The authors are grateful to the Lupin Pharmaceutical (Mumbai, India) for gift samples (telmisartan and ramipril) and to the Head-Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, India for providing laboratory facility for this research work.


  1. 1.
    Merck Index (2001) 13th edn. Merck & Co., inc., USAGoogle Scholar
  2. 2.
    Jain SD, Biradkar S, Periyandavar I, Sodhi SS, Anwariddin K, Gawde A, Baliga V, Gandewar K, Desai A (2005) Curr Ther Res 66(6):630–642CrossRefGoogle Scholar
  3. 3.
    Sharpe M, Jarvis B, Karen L (2001) Drugs 61(10):1501–1529CrossRefGoogle Scholar
  4. 4.
    Shen J (2005) Pharmazie 60(6):418–420Google Scholar
  5. 5.
    Jing N, Qun Z, Jingfang H, Bingren X, Feng TQ (2006) J Sep Sci 29(5):650–655CrossRefGoogle Scholar
  6. 6.
    Li P, Wang Y, Tang Y, Fawcett JP, Cui Y (2005) J Chromatogr B Analyt Tecnol Biomed Life Sci 828(1–2):126–129CrossRefGoogle Scholar
  7. 7.
    Jing N, Zhang M, Fan Y, Wen Y, Xing B, Feng YQ (2005) Chromatogr B 828:62–69CrossRefGoogle Scholar
  8. 8.
    Pallwd MS, Ragesh MN, Chatter PM, Bhat AR (2005) Ind J Pharma Sci 67:108–110Google Scholar
  9. 9.
    Pallwd MS, Ragesh MN, Chatter PM, Bhat AR (2006) Ind J Pharma Sci 68:685–686CrossRefGoogle Scholar
  10. 10.
    Kumar MV, Muley PR (2005) Indian Pharm 36:69–72Google Scholar
  11. 11.
    Wankhede SB, Tajne MK, Gupta KR, Wadodkar SG (2007) Ind J Pharma Sci 69:298–300CrossRefGoogle Scholar
  12. 12.
    Belal F, Al-Zaagi IA, Gadkariem EA, Abounassif MA (2001) J Pharma Biomed Anal 24(3):335–342CrossRefGoogle Scholar
  13. 13.
    Lu XY, Tu JZS, Liu J (2006) J Pharma Biomed Anal 40(2):478–483Google Scholar
  14. 14.
    Hanysova L, Vaclavkova M, Dohnal J, Klimes J (2005) J Pharma Biomed Anal 37(5):1179–1183CrossRefGoogle Scholar
  15. 15.
    Manna L, Volvo L, Alimonti S (2006) J Chromatographia 53(1):S271–S275CrossRefGoogle Scholar
  16. 16.
    Baing MM, Vaidya VV, Sane RT, Menon SN, Dalvi K (2006) J Chromatographia 64(5–6):293–296CrossRefGoogle Scholar
  17. 17.
    Gandhimathi R, Ninan TK, Varghese A (2004) Indian Drugs-Bombay 41(1):36–39Google Scholar
  18. 18.
    International Conference on Harmonisation: Guidelines for the “photostability testing of new drug substances, products, step 4”, Q1B. 1996Google Scholar
  19. 19.
    Singh S, Bakshi M (2000) Pharm Technol 26:24–31Google Scholar
  20. 20.
    Validation of analytical procedures: text and Methodology. In: ICH Harmonized Tripartite Guidelines Q2 (R1). November 2005Google Scholar

Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2008

Authors and Affiliations

  • Kiran R. Patil
    • 1
    • 2
  • Vipul P. Rane
    • 1
    • 2
  • Jaiprakash N. Sangshetti
    • 1
  • Devanand B. Shinde
    • 1
  1. 1.Department of Chemical TechnologyDr. Babasaheb Ambedkar Marathwada UniversityAurangabadIndia
  2. 2.Wockhardt Research CentreAurangabadIndia

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