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ACTA Pharmaceutica Sciencia 2023 , Vol 61 , Num 4
Determination of quality of tablets containing irbesartan and hydrochlorothiazide via newly developed and validated simultaneous HPLC method
Berna KAVAL 1-2 Saniye OZCAN 3 Mustafa CELEBIER 4 Mustafa S. KAYNAK 2
1 Mugla Sıtkı Kocman University, Koycegiz Vocational School of Health Services, Department of Pharmacy Services, Mugla, Türkiye
2 Anadolu University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Eskisehir, Türkiye
3 Anadolu University, Faculty of Pharmacy, Department of Analytical Chemistry, Eskisehir, Türkiye
4 Faculty of Pharmacy, Department of Analytical Chemistry, Hacettepe University, Ankara, Türkiye
DOI : 10.23893/1307-2080.APS6126 Irbesartan and hydrochlorothiazide are common combination drugs used to treat hypertension. The goal of this study was to develop an HPLC method for simultaneous quantification of IRB and HCT and to use this method in tablet quality control tests. The mobile phase in gradient elution mode HPLC method was 30 mM sodium acetate buffer (pH:5.00): water: ACN (40:40:20, v/v/v %) at a flow rate of 0.6 mL/min and 230 nm and that employed avanafil as an internal standard. The ICHQ1 (R2) guideline was used to determine its applicability and capacity studies. The tablets were then subjected to weight variation, thickness-width-length tests, hardness tests, content uniformity, and dissolution tests as quality control tests. The mean recovery for hydrochlorothiazide in the accuracy study was 99.76% and 99.10% for irbesartan. The dissolution test results were discovered that 85% of both active substances were released into the dissolution medium within the first 15 minutes. Keywords : Fixed dosage form, hydrochlorothiazide, irbesartan, tablet quality control tests

Istanbul Medipol University