2025, Vol. 6, Issue 2, Part A
QbD based analytical method development for simultaneous quantification of valsartan and hydrochlorothiazide in bulk and formulation
Author(s): Mulchand Shende, Nayna Bhoyar and Dipali Madavi
Abstract: The UV spectrophotometry analytical method was developed and validated using QbD to simultaneously assess valsartan (VAL) and hydrochlorothiazide (HCT) in both bulk and dosage form. The central composite design (CCD) approach was employed for the initial parameter selection to assess the robustness of the method. The method was found to be linear with R2 >0.99 between the range of 2-18𝜇g/mL for both drugs using methanol and 0.1N NaOH (55:45) as solvent. The mean percentage recovery for VAL and HCT were found to be 101.21%, 101.84%, and 100.16 %, 100.60%, respectively. The precision of the method was found within the limits (% RSD<2%). Robustness and ruggedness were found to be within limits (% RSD < 2%) for the developed methods. The LOD and LOQ were satisfactory and in the acceptable range. The QbD-developed spectrophotometric method for simultaneous VAL and HCT quantification in bulk and formulation is more precise, simple, quick, reliable, economical, and specific.
Pages: 37-49 | Views: 73 | Downloads: 27
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How to cite this article:
Mulchand Shende, Nayna Bhoyar, Dipali Madavi. QbD based analytical method development for simultaneous quantification of valsartan and hydrochlorothiazide in bulk and formulation. J Res Chem 2025;6(2):37-49.
