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Journal . 2025
License: CC BY
Data sources: Datacite
ZENODO
Journal . 2025
License: CC BY
Data sources: Datacite
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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;

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

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).

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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