盐酸普拉克索缓释微丸胶囊的制备及有关物质检测 点击下载
论文标题: 盐酸普拉克索缓释微丸胶囊的制备及有关物质检测
英文标题:
中文摘要: 目的:制备盐酸普拉克索缓释微丸胶囊,建立其有关物质的检测方法。方法:采用流化床空气悬浮包衣法制备载药丸芯,以乙基纤维素水分散体(Surelease®)进行包衣,制成盐酸普拉克索缓释微丸,装入胶囊即可。采用高效液相色谱(HPLC)法检测缓释微丸中有关物质,色谱柱为Capcell PAK MG-Ⅱ C18(150 mm×4.6 mm,5 μm);梯度洗脱,流动相A为甲酸铵缓冲液(pH 5.0),流动相B为甲醇;流速为1.0 ml/min;二极管阵列检测器,检测波长为240、262、326 nm;进样量为80 μl。结果:该色谱条件下,盐酸普拉克索能与7种有关物质完全分离,且空白辅料不干扰测定,7种有关物质检测质量浓度的线性范围均为0.2~2 μg/ml(r>0.999 0),检测限为0.5~1.8 ng,定量限为1.7~5.9 ng,平均回收率为98.93%~102.0%(RSD为1.90%~0.24%,n=9),精密度和稳定性试验的RSD均小于1.0%(n=5)。所制得的盐酸普拉克索缓释微丸胶囊中仅检测出1种有关物质。结论:成功制得盐酸普拉克索缓释微丸胶囊;所建立的HPLC法可用于其有关物质的检测。
英文摘要: OBJECTIVE: To prepare Pramipexole dihydrochloride sustained-release pellets capsules and to establish a method for the determination of related substances. METHODS: Drug loaded core was prepared by fluid bed air suspension coating method, and pramipexole dihydrochloride pellets were prepared using Surelease® as coating materials and put into capsules. HPLC method was used to determine related substance in sustained-release pellets; the determination was performed on Capcell PAK MG-Ⅱ C18 column (150 mm×4.6 mm, 5 μm) with mobile phase A consisted of ammonium formate buffer solution (pH 5.0) and mobile phase B consisted of methanol for gradient elution at flow rate of 1.0 ml/min; diode array detector was used with detection wavelength of 240, 262, 326 nm and injection volume of 80 μl. RESULTS: Pramipexole dihydrochloride and 7 kinds of related substances were separated by the established HPLC conditions. The blank excipient did not interfere with the assay of the related substances. The linear ranges of 7 related substances were 0.2-2 μg/ml (r>0.999 0); the limit of detection ranged 0.5-1.8 ng, and the limit of quantitation ranged 1.7-5.9 ng; average recovery ranged 98.93%-102.0% (RSD were 1.90%-0.24%,n=9). RSD of precision and stability test were all lower than 1.0% (n=5). Only one related substance was found in prepared Pramipexole dihydrochloride pellets capsules. CONCLUSIONS: Pramipexole dihydrochloride pellets capsules are prepared successfully. Established HPLC method can be used for the determination of its related substances.
期刊: 2016年第27卷第31期
作者: 戈文兰,张根元
英文作者: GE Wenlan,ZHANG Genyuan
关键字: 盐酸普拉克索;缓释微丸;胶囊;制备;高效液相色谱法;有关物质;检测
KEYWORDS: Pramipexole dihydrochloride; Sustained-release pellets; Capsules; Preparation; HPLC method; Related substances; Determination
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