A Novel, Stability-indicating Method for Analyzing Degradation Impurities in Hydrochlorothiazide and Irbesartan...

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

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.

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.

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. Here, we are first time reporting the method for simultaneous determination of eight impurities in Hydrochlorothiazide and Irbesartan combination drug with decent accuracy and precision.

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