Volume : 12, Issue : 03, March – 2025
Title:
DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF TRANEXAMIC ACID AND ETHAMSYLATE IN BULK AND TABLET DOSAGE FORM
Authors :
Md.Arshad, Dr.Sumer Singh, Dr.Abdul Sayeed
Abstract :
The present study demonstrates the method development and validation for simultaneous estimation of Ethamsylate & Tranexamic acid in combined pharmaceutical dosage form by using RP-HPLC along with the stability studies. According to ICH guidelines for stability testing of new drug substances and products, both the drugs were subjected to various stress conditions. The chromatographic separation was carried out on ALLIANCE C18 column with the dimensions of 250 mm x 4.6 mm x 5µm using Waters 2695 HPLC instrument equipped with 2998 series of PDA detector. The isocratic mobile phase used was made up of Phosphate Buffer with pH adjusted at 3.1 & Acetonitrile (ACN) in the ratio 80:20 v/v with the flow rate of 1.0 ml /min and both the drugs have been detected using UV detector at 250 nm. At room temperature Ethamsylate and Tranexamic acid were found to have retention times of 2.522 & 4.739 minutes respectively with a total run time of 7 minutes. The developed method was validated by utilizing various validation parameters and the force degradation & stability studies were applied to analyse the stability and to identify settlement of the degradation products. The established method can be applied for the simultaneous determination of ETS & TXA in combined dosage form.
Keywords: ETS (Ethamsylate), TXA (Tranexamic acid) ACN(Acetonitrile).
Cite This Article:
Please cite this article in press Md.Arshad et al., Development And Validation Of A Stability Indicating Rp-Hplc Method For The Simultaneous Determination Of Tranexamic Acid And Ethamsylate In Bulk And Tablet Dosage Form., Indo Am. J. P. Sci, 2025; 12(05).
Number of Downloads : 10
References:
1. ChromatographyHandBookof HPLC,Katz,Wiley&Sons,pp.14–16, 2002.
2. R. L. Henry, “The early days of HPLC at Dupont,” Chromatography Online, Avanstar Communications Inc., 1 Feb. 2009.
3. IUPAC,CompendiumofChemicalTerminology,2nded. (TheGoldBook),1997.
4. O. D. Agrawal and N. B. Telang, “Development and validation of UV spectrophotometric method for estimation of Benfotiamine in bulk and dosage form,” Asian J. Pharm. Ana., vol. 6, no. 3, pp. 133–137, 2016.
5. W. J. Lough and I. W. Wainer, High Performance Liquid Chromatography Fundamental Principles and Practice, Blackie Academic & Professional, p. 120.
6. D. Mac Dougall, W. B. Crummett et al., “Guidelines for data acquisitionand data quality evaluation in environmental chemistry,” Anal. Chem., vol. 52, pp. 2242– 2249.
7. “Method Validation: Archived copy,” archived from the original on 11 Sept.2011.
8. Health Sciences Authority, “Guidance notes on analytical method validation: Methodology.”
9. Y. Vander Heyden, S. W. Smithet al., “Guidance for robustness/ruggedness tests in method validation,” Journal of Pharmaceutical and Biomedical Analysis, vol. 24, no. 5–6, pp. 723–753, 2001.
10. Subcommittee E11.20onTest MethodEvaluation and QualityControl, “Standard practice for use of the terms precision and bias in ASTM test methods,” 2014.
11. E.Lukacs,CharacteristicFunctions,Griffin,London, 1970.
12. J. M. Bland and D. G. Altman, “Statistics notes: measurement error,” BMJ, vol. 312, no. 7047, p. 1654, 1996.
13. “FDA issues dietary supplements final rule,” U.S.Food and Drug Administration, press release, 22 June 2007.
14. K.Robinson,“GLP sand the importance of standard operating procedures,”Bio Pharm International,1Aug.2003.
15. ICH Harmonised Tripartite Guideline Q2(R1), Current Step 4 version Parent Guideline, 27 Oct. 1994.
16. “Validation definition and FDA, regulatory agencies guidelines requirement,” accessed 27 Feb. 2014.