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Total error-based validation including the experimental design-based robustness evaluation of a stability-indicating method for the simultaneous quantification of hydrochlorothiazide and valsartan in tablet formulations

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A gradient reversed phase high-performance liquid chromatography (RP-HPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet formulation during forced degradation studies was developed. This method was validated using a novel approach, namely, the accuracy profile or total errors approach. The robustness of the method was evaluated using a Plackett-Burman design for eight factors. The algorithm of Dong was applied to determine the significant factor effects. The validation results showed that the method is precise (RSD: 1.14% for HCT and 0.43% for VS) and accurate (mean recovery: 99.90% for HCT and 99.98% for VS). On the other hand, the results of the robustness study showed that the type of column was the important factor which affects a number of responses, namely, the asymmetry factor (AF), retention time (RT), and resolution (RS). However, the assay results were not affected; therefore, the method can be considered robust. Finally, the method was applied to study the stability of HCT and VS under forced conditions. Significant results were obtained with basic hydrolysis, oxidation, and thermal stress, while the accelerated and acidic conditions did not affect the stability of HCT or VS.
Rocznik
Strony
195--214
Opis fizyczny
Bibliogr. 31 poz., rys., tab.
Twórcy
autor
  • Mohammed V University Research Team of Pharmaceutical and Toxicological Analysis — Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy Soussi, Rabat Morocco
  • Ministry of Health Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy Rabat Morocco
autor
  • Mohammed V University Research Team of Pharmaceutical and Toxicological Analysis — Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy Soussi, Rabat Morocco
  • Ministry of Health Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy Rabat Morocco
autor
  • Ministry of Health Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy Rabat Morocco
autor
  • Ministry of Health Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy Rabat Morocco
autor
  • Mohammed V University Research Team of Pharmaceutical and Toxicological Analysis — Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy Soussi, Rabat Morocco
autor
  • University of Liège, B-36 Laboratory of Analytical Chemistry, Institute of Pharmacy B-4000 Liège Belgium
autor
  • Vrije Universiteit Brussel Anaytical Chemistry and Pharmaceutical Technology Laarbeeklaan 103 1090 Brussel Belgium
autor
  • Mohammed V University Research Team of Pharmaceutical and Toxicological Analysis — Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy Soussi, Rabat Morocco
Bibliografia
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Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-4f1d048c-8044-40c4-ac50-e43b812adbca
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