Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease
Abstract
Novel drug Tegoprazan has been introduced for the treatment of gastro-esophageal reflux disease. Accurate and precise thin layer chromatographic method has been developed and validated for estimation of tegoprazan. Silica gel G 60 F254 (20cm×20cm) coated aluminium backed plates were used as stationary phase and mixture of Toluene: Methanol (7.5: 2.5 v/v) was used as mobile phase. The compact band (Rf values 0.53 ± 0.1) was obtained for Tegoprazan. The method was found to be linear in the concentration range of 100 -700 ng/band with a linear regression equation showing linear relationship with R2 =0.9944. The method was validated as per ICH Q2 (R2) guidelines Forced degradation studies were carried out to assess molecule’s intrinsic stability, using acid and base hydrolysis, oxidative stress and photolytic degradation. Forced degradation study revealed that Tegoprazan was highly susceptible to acid hydrolysis. Greenness assessment for develop method was conducted using AGREE and White analytical chemistry. The evaluation confirmed environmentally friendly nature of developed method.
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