Validation of a Stability-Indicating HPLC Method for the Determination of Amiodarone HC1 and Its Related Substances in Amiodarone HC1 Injection

摘要

The validation of a gradient high performance liquid chromatographic (HPLC) procedure employing ultraviolet (UV) detection for the analysis of amiodarone HC1 and two of its related substances in Amiodarone HC1 Injection (drug product) is reported. The method is reproducible, accurate, and selective for amiodarone HC1 and the two known related substances. The peak area response versus concentration was demon-strated to be linear over a range of 50- 150% for the assay preparation, as well as over a range of 0.1-0.3% for the related substance preparation range. Relative response factors were determined for the two available related substances. The precision (repeatability) of the method was demonstrated for both assay and related substances from six independent sample preparations. Intermediate precision was demonstrated between two separate chemists on two separate days and instruments. Accuracy of the method (percent recovery) was demonstrated for both amiodarone HC1 and each of the two available related substances. Specilicity was demonstrated by forced degradation of drug product under acid, base, heat, peroxide, and light conditions. A quantitation limit and detection limit is reported for amiodarone HC1 and each of the two available related substances. Preparations were demonstrated to be stable for up to 48 hours following their preparation, when stored under laboratory light at 25℃.