【摘要】 目的 通过气相色谱法建立盐酸美金刚缓释胶囊有关物质的检查方法，确保药品的杂质得到有效控制。方法 采用气相色谱法测定，用100%二甲基聚硅氧烷（或极性相近）为固定相的毛细管柱（DB-1, 30 m×0.53 mm, 1.0μm）；检测器为FID；载气为氮气；载气流速为3.5 m L·min^-1；分流比为10∶1；起始温度为80℃，以4℃·min^-1的升温速率升至200℃；进样口温度为210℃；检测器温度为300℃。结果 该方法能够有效区分盐酸美金刚与杂质峰，保证了良好的分离度和准确度。结论 该气相色谱法能够准确、可靠地测定盐酸美金刚缓释胶囊的有关物质，具有良好的专属性和准确性，适用于该药品的杂质控制。更多还原

【Abstract】 Objective To establish a gas chromatography（GC） method for the determination of related substances in memantine hydrochloride sustained-release capsules to ensure effective control of pharmaceutical impurities. Methods A capillary column（DB-1, 30 m × 0.53 mm, 1.0 μm） with 100% dimethylpolysiloxane（or equivalent polarity） stationary phase was employed. The detector was a flame ionization detector（FID）, with nitrogen as the carrier gas at a flow rate of 3.5 mL·min^-1 and a split ratio of 10:1. The temperature program started at 80 ℃ and increased to 200 ℃ at a rate of 4 ℃·min^-1. The injector and detector temperatures were set to 210 ℃ and 300 ℃, respectively. Results The method effectively resolved the peaks of memantine hydrochloride and its impurities with the excellent resolution and accuracy. Conclusion The developed GC method is accurate, reliable, and specific for determining related substances in memantine hydrochloride sustained-release capsules, making it suitable for quality control of impurities in this pharmaceutical product.更多还原