Determination of quality of tablets containing irbesartan and hydrochlorothiazide via newly developed and validated simultaneous HPLC method

Kaval B., ÖZCAN S., ÇELEBİER M., KAYNAK M. S.

Acta Pharmaceutica Sciencia, cilt.61, sa.4, ss.397-413, 2023 (Scopus) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 61 Sayı: 4
  • Basım Tarihi: 2023
  • Doi Numarası: 10.23893/1307-2080.aps6126
  • Dergi Adı: Acta Pharmaceutica Sciencia
  • Derginin Tarandığı İndeksler: Scopus, EMBASE
  • Sayfa Sayıları: ss.397-413
  • Anahtar Kelimeler: Fixed dosage form, hydrochlorothiazide, irbesartan, tablet quality control tests
  • Hacettepe Üniversitesi Adresli: Evet

Özet

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 stu-dies. 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.