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

• Autorzy: Elkarbane M. , Amood M. , Bouchafra H. , Azougagh M. , Cherrah Y. , Hubert Ph. , Heyden Y. , Bouklouze A.
• 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.

Słowa kluczowe

EN

accuracy profile; total errors approach; robustness testing; stability-indicating method; forced degradation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 2
• Strony: 195--214
• Opis fizyczny: Bibliogr. 31 poz., rys., tab.

Twórcy

autor

Elkarbane M.

• 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

Amood M.

• 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

Bouchafra H.

• Ministry of Health Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy Rabat Morocco

autor

Azougagh M.

• Ministry of Health Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy Rabat Morocco

autor

Cherrah Y.

• Mohammed V University Research Team of Pharmaceutical and Toxicological Analysis — Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy Soussi, Rabat Morocco

autor

Hubert Ph.

• University of Liège, B-36 Laboratory of Analytical Chemistry, Institute of Pharmacy B-4000 Liège Belgium

autor

Heyden Y.

• Vrije Universiteit Brussel Anaytical Chemistry and Pharmaceutical Technology Laarbeeklaan 103 1090 Brussel Belgium

autor

Bouklouze A.

• Mohammed V University Research Team of Pharmaceutical and Toxicological Analysis — Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy Soussi, Rabat Morocco

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