A rapid and validated HPLC method for the simultaneous determination of valsartan and chlorthalidone in fixed-dose combination tablets


Bilgin Z. D., ERGİN KIZILÇAY G., Ertürk Toker S.

Journal of the Indian Chemical Society, cilt.103, sa.7, 2026 (SCI-Expanded, Scopus) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 103 Sayı: 7
  • Basım Tarihi: 2026
  • Doi Numarası: 10.1016/j.jics.2026.102744
  • Dergi Adı: Journal of the Indian Chemical Society
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Chemical Abstracts Core, EMBASE
  • Anahtar Kelimeler: Chlorthalidone, Fixed-dose combination tablets, HPLC, Method validation, Simultaneous determination, Valsartan
  • İstanbul Üniversitesi Adresli: Evet

Özet

A simple, rapid, and newly developed high-performance liquid chromatographic (HPLC) method was validated for the simultaneous determination of valsartan and chlorthalidone in fixed-dose combination tablets. Despite the widespread clinical use of this binary drug combination, no reported method currently enables the simultaneous determination of both drugs in a single chromatographic run. Chromatographic separation was achieved using a cyano (CN) column (250 × 4.6 mm, 5 μm) with an isocratic mobile phase consisting of acetate buffer (pH 4.5) and acetonitrile (80:20, v/v) at a flow rate of 1.5 mL/min, with detection at 276 nm using a photodiode array detector. The method exhibited excellent linearity (r2 = 0.9995) over concentration ranges of 80.0–480.0 μg/mL for valsartan and 62.5–375.0 μg/mL for chlorthalidone. The limits of quantification were 3.30 μg/mL and 7.81 μg/mL, respectively. Recovery values ranged from 99.97% to 102.26%, while precision values were within acceptable limits (RSD% ' 2.0%). The method was successfully applied to tablet formulations, and the results were statistically comparable to those obtained using official USP methods (t- and F-tests, p ' 0.05), supporting its suitability for routine quality control applications in line with pharmacopeial expectations. The proposed method provides a reliable and practical analytical approach for the simultaneous determination of valsartan and chlorthalidone in pharmaceutical formulations.