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image of A Novel, Stability-indicating Method for Analyzing Degradation Impurities in Hydrochlorothiazide and Irbesartan Tablets Using RP-HPLC

Abstract

Introduction

Well-known antihypertensive medications, hydrochlorothiazide and irbesartan, are sometimes taken as a low-dose combination in a single pill.

Aims

The aim of this research is to create and verify a standard screening test for identifying process-related degradation in tablets containing irbesartan and hydrochlorothiazide. The objective of the study was to report the quality and robust method of HPLC for impurities in the mentioned drugs.

Materials and Methods

Separation was accomplished using a Kromasil L7 column (250 x 4.6 mm 5 μ). Furthermore, a 50 x 4.6 mm ghost-busting column was set up. 0.1% orthophosphoric acid was used in mobile phase A, and acetonitrile was used in mobile phase B. Infinity 1290 was used to conduct the analysis at a fixed flow rate of 1.2 mL/minute. At 220 nm, detection was carried out. The temperature in the column oven was kept at 30°C.

Results

For eight impurities, regression analyses show a correlation coefficient value greater than 0.999. The approach was to demonstrate superior recoveries for impurities linked to hydrochlorothiazide and irbesartan (89.7-108.9%), and the limit of quantification for hydrochloro thiazide Related Compound-A is 0.248 ppm, chlorothiazide 0.251 ppm, chloro hydrochlorothiazide 0.252 ppm, irbesartan related compound-A 1.214 ppm, triphenyl methanol 1.210 ppm, IB-23 1.198 ppm, trityl methyl ether 1.204 ppm and KL-2 1.196 ppm.

Conclusion

The recommended method was well evaluated and can be used for routine examination of the drug impurity studies and mixtures.

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2025-05-22
2025-10-19

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A Novel, Stability-indicating Method for Analyzing Degradation Impurities in Hydrochlorothiazide and Irbesartan Tablets Using RP-HPLC
Bentham Science Publishers ; https://doi.org/10.2174/0125899775364137250512115928
/content/journals/cdrr/10.2174/0125899775364137250512115928
/content/journals/cdrr/10.2174/0125899775364137250512115928
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  • Article Type:     Research Article
Keywords: validation ; HPLC ; Irbesartan ; hydrochlorothiazide ; SIAM ; impurities

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