Volume : 11, Issue : 03, March – 2024

Title:

DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF IRBESARTAN AND HYDROCHLOROTHIAZIDE IN PHARMACEUTICAL DOSAGE FORMS.

Authors :

B.Himabindu*, K.Usha, Dr.L.Harikiran

Abstract :

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Irbesartan and Hydrochlorothiazide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Phosphate Buffer pH 3.5 (65:35) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 270 nm. The retention time of the Irbesartan and Hydrochlorothiazide was 2.456, 4.312±0.02min respectively. The method produce linear responses in the concentration range of 5-25mg/ml of Irbesartanand 2.5-12.5mg/ml of Hydrochlorothiazide. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords: Irbesartan, Hydrochlorothiazide, RP-HPLC, validation.

Cite This Article:

Please cite this article in press B.Himabindu et al, Development And Validation Of A Reversed-phase HPLC Method For Simultaneous Determination Of Irbesartan And Hydrochlorothiazide In Pharmaceutical Dosage Forms.,Indo Am. J. P. Sci, 2024; 11 (3).

Number of Downloads : 10

References:

1. Shetti, P.D. High Performance Liquid Chromatography. 2001; 116.
2. The Merck Index, an encyclopedia of chemicals, drugs and biological. Fourteenth Edn. USA; 2006.
3. Beckett, A.H.; Stenlake, J.B. Practical Pharmaceutical Chemistry, 4thEdn., C.B.S. Publications, 1.
4. Malik, V. Drugs and Cosmetics Act 1940, 16thEdn., Eastern Book Company, Lucknow, 5.
5. Willard, H.H.; Merit, L.L.; Dean, F.A.; Settle, F.A. Instrumental methods of analysis, 7thEdn., C.B.S. Publishers, New Delhi, 2002.
6. Mendham, J.; Denney, R.C.; Barnes, V; Thomas, M.J.K. Vogel’s Text book of Qualitative Chemical Analysis, 6thEdn., 261-287.
7. Skoog, D.A.; West, D.M. Fundamentals of Analytical Chemistry, 7thEdn.
8. Sharma, B.K., Instrumental methods of Chemical analysis, 19thEdn., 2000.
9. Willard, H.H.; Merrit, L.L.; Dean. J.A., Instrumental methods of analysis, 7thEdn., CBS Publishers, New Delhi.
10. Khopkar, S.M. Basic concepts of analytical chemistry, 2nd edition, 2005.
11. Tips on Liquid Chromatography, Waters www.waters.com.
12. Validationof Analytical Procedures: Methodology, ICH Tripartite Guidelines 1996.
13. Validation of Analytical Procedures, ICH Harmonized Tripartite Guidelines 1994.
14. ICH, Q2A Text on validation of analytical procedures, Oct, 1994www.ich.org.
15. ICH, Q3B Validation of analytical procedures: methodology, Nov, 1996