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

Abstract

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, 100 ´ 4.6 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 ³ 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.

Keywords

• carvedilol
• 4-hydroxycarbazole
• RP-HPLC
• stability