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
ELKARBANE, M; AMOOD AL-KAMARANY, M; BOUCHAFRA, Het al.
[en] A gradient reversed phase high-performance liquid chromatography (RPHPLC)
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.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
ELKARBANE, M; Mohammed V University, Soussi, Rabat, Morocco
AMOOD AL-KAMARANY, M; Mohammed V University, Soussi, Rabat, Morocco
BOUCHAFRA, H; Division of Drugs and Pharmacy, Ministry of Health, Rabat, Morocco
AZOUGAGH, M; Division of Drugs and Pharmacy, Ministry of Health, Rabat, Morocco
CHERRAH, Yaya; Mohammed V University, Soussi, Rabat, Morocco
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
BOUKLOUZE, Abdelaziz; Mohammed V University, Soussi, Rabat, Morocco
Language :
English
Title :
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
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