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Wang, B., Zhang, W., Wang, P., Zhou, Q., Zhang, K., Zhang, J., et al. (2023) Nonclinical Study of the Active Components of Doxorubicin Hydrochloride Liposome Injection in vivo. Pharmacology & Pharmacy, 14, 363-375.
https://doi.org/10.4236/pp.2023.149023

has been cited by the following article:

• TITLE: Method Verification and Validation of Hydralazine Hydrochloride: Spectrophotometric Analysis in Pure and Pharmaceutical Formulations

  AUTHORS: Laila Abdullah Alshatti

  KEYWORDS: Spectrophotometry, Validation, Hydralazine Hydrochloride, International Conference on Harmonization Q2 (R1)

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.15 No.7, July 24, 2024

  ABSTRACT: The new method proposed is based on the formation of hydralazine-Bromophenol blue ion pair simply and without further extraction or heating. The ion pair was prepared in the presence of pH 3 citrate buffer forming a yellow-colored chromogen. A new maximum UV-visible band formed at 416 nm. The color was stable for more than 10 hours and obeyed Beer’s Law over the concentration range of 10 - 50 µg/mL. The calculated molar absorptivity and Sandell’s sensitivity were 1.01 × 104 L∙mol−1∙cm−1 and 0.0514 µg/mL, respectively. The elements of method validation stipulated by The International Conference on Harmonization [Q2 (R1)] were applied for hydralazine hydrochloride assay in pure and pharmaceutical tablet formulation. The average recoveries of the pure solution and the pharmaceutical formulation were 98.94% and 99.50%, respectively. The results were statistically compared by F-test, which indicates that the method can be precise and repeatable for both pure and pharmaceutical solutions. The method was found to be accurate, reproducible, and cost-effective, and validated for the assay of hydralazine in terms of the routine quality control.