DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR ESTIMATION OF TELMISARTAN IN HUMAN PLASMA

  • P. Ashok Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
  • S. T. Narenderan Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
  • S. N. Meyyanathan Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
  • B. Babu Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
  • R. Vadivelan Department of Pharmacology, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India

Abstract

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.

Keywords: Telmisartan, HPLC, Protein precipitation, US-FDA validation

References

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How to Cite
Ashok, P., Narenderan, S. T., Meyyanathan, S. N., Babu, B., & Vadivelan, R. (2019). DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR ESTIMATION OF TELMISARTAN IN HUMAN PLASMA. International Journal of Applied Pharmaceutics, 11(1), 237-240. https://doi.org/10.22159/ijap.2019v11i1.30513
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