Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method

• Main Authors: Stojanović Jelena, Vladimirov Sote, Marinković Valentina, Veličković Dragan, Sibinović Predrag
• Format: Article
• Language: English
• Published: Serbian Chemical Society 2007-01-01
• Series: Journal of the Serbian Chemical Society
• Subjects: carvedilol; 4-hydroxycarbazole; rp-hplc; stability
• Online Access: http://www.doiserbia.nb.rs/img/doi/0352-5139/2007/0352-51390701037S.pdf

A sensitive, selective, precise and stability-indicating, new high-performance liquid chromatographic method for the analysis of carvedilol both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. The method was validated for linearity, selectivity, precision, robustness, LOD, LOQ and accuracy. The chromatographic separation was achieved on a Chromolit RP8e, 100x4.6 mm, analytical column. The mobile phase consisted of a mixture of acetonitrile and water (45:55, V/V) (pH 2.5), pH adjusted with formic acid. The absorbance was monitored with a UV detector at 280 nm and the temperature of the analyses was 40°C. The flow rate was 0.5 mL/min. The linearity (r≥ 0.999), reproducibility (0.68-1.27 %) and recovery (99.71-101.58) were found to be satisfactory. This method enables the simultaneous determination of carvedilol and its degradation products, as well as stability. .