Development and validation of a reversed-phase high-performance liquid chromatography-ultraviolet method for abemaciclib-related substance detection in bulk drugs

Abemaciclib is an effective selective cyclin-dependent kinases 4 and 6 inhibitors for cancer therapy. The abemaciclib-related substances influence its efficacy and safety, and are important in process preparation studies and quality control. Thus, a reversed-phase high-performance liquid chromatography method was developed and validated for the detection of related substances in its bulk drug. The separation of abemaciclib and related substances was performed on a Phenomenon Gemini C18 column (4.6 x 250 mm, 5 mu m) with a flow rate of 1.0 ml/min. The ultraviolet detection wavelength was 280 nm. Mobile phase A was composed of a mixed solution of aqueous solution and acetonitrile (9:1, v/v). The aqueous solution (pH 2.5) contained 0.025-mM potassium dihydrogen phosphate solution and 0.4% triethylamine. Mobile phase B was composed of acetonitrile. This novel method exhibits good system suitability, specificity, precision, stability, linearity (0.1-20 mu g/ml), repeatability, and durability. Among abemaciclib and related substances, the lowest limit of detection and quantitation were 0.02 and 0.06 mu g/ml, respectively, for abemaciclib. The recovery rates for related substances were above 95%. In addition, a novel degradation product was found during the process. In summary, a reliable reversed-phase high-performance liquid chromatography method was developed for abemaciclib-related substance detection in bulk drugs.

Automated summary

A reliable reversed-phase high-performance liquid chromatography method was developed for the detection of related substances in the bulk drug of abemaciclib. This method exhibits good system suitability, specificity, precision, and stability, and is of great significance in the quality control of this drug.