Drug development and industrial pharmacy · 2025
Stability indicating HPTLC - densitometric method for estimation of vonoprazan fumarate.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Parmar Mitalben S, Shah Dimal A, Chhalotiya Usmangani K
Аннотация
OBJECTIVES: High performance thin layer chromatography method was developed and validated for analysis of vonoprazan fumarate. An Alkaline forced degradation kinetic study was performed to find out probable rate of degradation of vonoprazan fumarate.
MATERIAL AND METHODS: Aluminum packed TLC plates precoated with silica gel 60 F 254 were used as stationary phase and Methanol: Toluene: triethylamine (6: 4: 0.1 v/v/v) was used as mobile phase. The detection was carried out at 267 nm wavelength as absorbance mode. HPTLC/MS analysis study was performed to detect alkaline degradant.
RESULTS: A compact band (Rf value of 0.43 ± 0.1) was obtained for vonoprazan fumarate. Regression analysis shows a good linear relationship (R2 = 0.9996) between peak area and concentration in the range 200-1200 ng/band. The accuracy determined by standard addition method for vonoprazan fumarate and percentage recovery was found to be 99.72% - 101.74%. Forced degradation stability study was performed under different stress conditions including hydrolytic, oxidative, thermal and photolytic. Degradation was observed under alkaline condition and it was found to follow first order degradation kinetic. The possible structure of base degradants was also determined using HPTLC-MS analysis. The method was successfully applied for the estimation of drug in synthetic mixture.
CONCLUSION: A New, Simple, precise and accurate method has been developed and validated for the quantification of vonoprazan fumarate. Forced degradation studies were performed. The method can be used for quality control and stability sample evaluation of vonoprazan fumarate.
MATERIAL AND METHODS: Aluminum packed TLC plates precoated with silica gel 60 F 254 were used as stationary phase and Methanol: Toluene: triethylamine (6: 4: 0.1 v/v/v) was used as mobile phase. The detection was carried out at 267 nm wavelength as absorbance mode. HPTLC/MS analysis study was performed to detect alkaline degradant.
RESULTS: A compact band (Rf value of 0.43 ± 0.1) was obtained for vonoprazan fumarate. Regression analysis shows a good linear relationship (R2 = 0.9996) between peak area and concentration in the range 200-1200 ng/band. The accuracy determined by standard addition method for vonoprazan fumarate and percentage recovery was found to be 99.72% - 101.74%. Forced degradation stability study was performed under different stress conditions including hydrolytic, oxidative, thermal and photolytic. Degradation was observed under alkaline condition and it was found to follow first order degradation kinetic. The possible structure of base degradants was also determined using HPTLC-MS analysis. The method was successfully applied for the estimation of drug in synthetic mixture.
CONCLUSION: A New, Simple, precise and accurate method has been developed and validated for the quantification of vonoprazan fumarate. Forced degradation studies were performed. The method can be used for quality control and stability sample evaluation of vonoprazan fumarate.