US EPA

7491821 

Journal Article 

YPSK-UV ile Tablet Formülasyonunda Gliburid ve Ä°lgili Maddeleri İçin Bir Analitik Yöntem Geliştirilmesi ve Validasyonu 

Sudha, T; Krishna, V; Kumar, VRR 

2014 

Turkish Pharmacists Association 

11 

3 

307-316 

English 

A reverse phase liquid chromatographic method was developed for the determination of purity of glyburide drug substance and drug product in bulk samples and pharmaceutical dosage form in the presence of its impurities and degradation product. This method is capable of separating all the related substance of glyburide along with impurities. This method also can be used for the estimation of assay of glyburide in drug substance as well as in drug product. The method was developed using Inertsil C8 Octyl decane silane (250 x 4.0 mm 5.0μm) column, buffer pH 5.3: acetonitrile in the ratio of 60:40 %v/v used as mobile phase. The elution compounds were monitored at 230 nm. The method was validated as per ICH guidelines demonstrating to the accurate and precise within the corresponding linear range of impurities from LOQ to 200%. The specificity of the method was investigated under different stress conditions including hydrolytic, oxidative, photolytic and thermal as recommended by ICH guidelines. Relevant degradation was found to be significantly in acid, hydrolysis and oxidative condition. Robustness against small modification in column oven temperature, flow rate and percentage of the mobile phase composition was ascertained. Limit of detection and limit of quantification were also determined. The peak purity indices (purity angle < purity threshold) obtained with the aid of PDA detection with satisfactory resolution between related impurities established the specificity of the determination. © 2014, Turkish Pharmacists Association. All rights reserved. 

Carbamate; Development; Glyburide; Sulphonamide; Validation; acetonitrile; buffer; glibenclamide; glibenclamide plus metformin; silane; accuracy; Article; chemical modification; controlled study; degradation; drug determination; drug impurity; drug structure; elution; flow rate; high performance liquid chromatography; hydrolysis; limit of detection; limit of quantitation; oxidative stress; pH; photolysis; practice guideline; tablet formulation; temperature stress; ultraviolet radiation; validation study