本文選題：鹽酸氨基葡萄糖 + N-乙酰氨基葡萄糖　； 參考：《中國藥學(xué)雜志》2017年04期

【摘要】：目的建立HPLC測定不同廠家鹽酸氨基葡萄糖制劑的含量及有關(guān)物質(zhì),考查了3種劑型8個廠家的產(chǎn)品質(zhì)量差異。方法采用Phenomenex Luna NH2色譜柱(4.6 mm×250 mm,5μm),以磷酸鹽緩沖液(稱取7.0 g磷酸氫二鉀溶解在適量水中,加0.5 m L氨水,加水稀釋至2 000 m L,用磷酸調(diào)節(jié)p H值至7.5)-乙腈(25∶75)為流動相,流速為1.5 m L·min~(-1),柱溫為30℃,檢測波長為195 nm。結(jié)果鹽酸氨基葡萄糖系統(tǒng)適用性試驗符合要求,主峰與相鄰雜質(zhì)峰之間的分離度大于1.5。鹽酸氨基葡萄糖在0.156 64~15.664 mg·m L~(-1)內(nèi)線性關(guān)系良好(r=0.999 9)。平均回收率為101.14%,RSD為1.20%(n=9)。結(jié)論本方法可同時測定鹽酸氨基葡萄糖的有關(guān)物質(zhì)和含量測定,為該產(chǎn)品的質(zhì)量控制提供參考。
[Abstract]:Objective to establish a HPLC method for the determination of glucosamine hydrochloride and its related substances in different factories, and to examine the quality differences of 8 kinds of preparations. Methods Phenomenex Luna NH _ 2 column (4.6 mm 脳 250mm ~ 5 渭 m),) -acetonitrile (25:75) -acetonitrile (25:75) was used as mobile phase with phosphate buffer solution (7.0 g dipotassium hydrogen phosphate dissolved in proper amount of water, adding 0.5 mL ammonia water, diluted to 2 000 mL with water, adjusted pH value to 7.5 mm with phosphoric acid). The flow rate was 1.5 mL / min ~ (-1), the column temperature was 30 鈩，

本文編號：2109774