RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM

  • Upendra Bhadoriya
  • Hemant Dhaked
  • Abhinandan Kumar Danodia

Abstract

A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Telmisartan in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on RP18, column (250×4.6mm) with a mobile phase composed of 0.025M potassium dihydrogen phosphate : acetonitrile : methanol (45:50:5) at a flow rate of 1ml/min. The detection was monitored at 216 nm. The calibration curve for Telmisartan was linear from 100 to 500 ng/ml. The interday and intraday precision was found to be within limits. LOD and LOQ for Telmisartan were found to be 27 ng/ml and 83 ng/ml. Accuracy and reproducibility were also found within range. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of Telmisartan in bulk and its tablet dosage forms.

Keywords: Telmisartan, RP-HPLC, Validation, Tablet.

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References

1. The Merck Index, Merck Research Laboratories, 14th Ed., Division of Merck & Co, Inc. Whitehouse Station NJ USA, 1569.
2. Martindale, the Complete Drug Reference, 36th Ed., the Pharmaceutical Press, London, Vol.1, 1409.
3. Code Q2A: Text on Validation of Analytical procedures. Step III Consensus guidelines. ICH Harmonized Tripartite Guidelines. 1994: 153
4. Code Q2B: Text on Validation of Analytical procedures. Step IV Consensus guidelines. ICH Harmonized Tripartite Guidelines. 1994: 1-8
5. Lloyd RS, Joseph JK; Joseph LG; Practical HPLC Method Development, John Wiley and Sons, Inc, Noida, 1997, 2, 235-251
6. David MB, Validating Chromatographic Methods – A Practical Guide, John Wiley and Sons, Inc, Noida, 2006, 6, 1-5
7. ICH Harmonized Tripartite Guidelines, Validation of Analytical Procedures: Text and Methodology, 1994, Q2R (1)
8. Center for Drug Evaluation and Research (CDER), 1994. Reviewer Guidance, Validation of Chromatographic Methods
9. Robert AN; Alfred HW; Pharmaceutical Process Validation, Replica Press P. Ltd, New Delhi, 2003, 3, 507-24.
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How to Cite
Bhadoriya, U., H. Dhaked, and A. K. Danodia. “RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 2, Feb. 2018, pp. 61-64, doi:10.22270/ijdra.v1i2.112.