愈酚维林片的溶出度测定方法研究 点击下载
论文标题: 愈酚维林片的溶出度测定方法研究
英文标题:
中文摘要: 目的:建立愈酚维林片溶出度的测定方法,并比较不同厂家制剂的差异。方法:采用浆法进行溶出,以水为溶出介质,体积为1 000 mL,转速为75 r/min,取样时间为45 min;采用高效液相色谱法测定制剂中枸橼酸喷托维林和愈创甘油醚的溶出度:色谱柱为CAPCELL PAK C18 MGⅡ S-5,流动相为乙腈-磷酸三乙胺缓冲溶液(pH 2.6±0.05)(33 ∶ 67,V/V),流速为1.0 mL/min,检测波长为215 nm(枸橼酸喷托维林)、275 nm(愈创甘油醚),柱温为35 ℃,进样量为20 μL。结果:枸橼酸喷托维林、愈创甘油醚检测质量浓度线性范围分别为5.091 6~50.915 5 μg/mL(r=0.999 9)、29.999 5~299.995 2 μg/mL(r=0.999 9);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为97.90%~100.68%(RSD=0.95%,n=9)、97.09%~101.85%(RSD=1.32%,n=9)。6个厂家样品中枸橼酸喷托维林的平均累积溶出度分别为12%、98%、66%、97%、91%、32%(n=3),愈创甘油醚分别为8%、95%、68%、90%、93%、18%(n=3)。结论:该方法简便、准确、灵敏度高、专属性强,适于愈酚维林片的溶出度测定;不同厂家样品及同一厂家同批次样品间的溶出度均存在较大差异。
英文摘要: OBJECTIVE: To establish a method for the dissolution determination of Pentoxyverine citrate and guaifenesin tablets, and to compare the difference of preparations from different manufactures. METHODS: The paddle method was used to determine the dissolution, using water as medium with medium volume of 1 000 mL and rotation speed of 75 r/min,sampling at 45 min. HPLC method was used to determine the accumulative dissolution of pentoxyverine citrate and guaifenesin: CAPCELL PAK C18 MGⅡ S-5 column; mobile phase of acetonitrile-triethylamine phosphoric buffer solution(pH 2.6±0.05)(33 ∶ 67,V/V), flow rate of 1.0 mL/min, detection wavelength of 215 nm (pentoxyverine citrate) and 275 nm (guaifenesin), column temperature of 35 ℃, sample size of 20 μL. RESULTS: The linear range of pentoxyverine citrate and guaifenesin were 5.091 6-50.915 5 μg/mL(r=0.999 9) and 29.999 5-299.995 2 μg/mL(r=0.999 9), respectively. RSDs of precision, stability and reproducibility tests were all lower than 2.0%. Average recoveries were 97.90%-100.68%(RSD=0.95%,n=9) and 97.09%-101.85%(RSD=1.32%,n=9).  Average accumulative dissolution of  pentoxyverine citrate in 6 manufactures of samples were 12%, 98%, 66%, 97%, 91%, 32%(n=3); those of guaifenesin were 8%, 95%, 68%, 90%, 93%, 18%(n=3), respectively. CONCLUSIONS: The method is simple, accurate, sensitive, specific and suitable for the dissolution determination of Pentoxyverine citrate and guaifenesin tablets. The dissolution of samples between different manufactures and the same manufactures different batches are quite different.
期刊: 2017年第28卷第12期
作者: 李筱玲,刘敏,李美芳,李玉兰,王铁杰
英文作者: LI Xiaoling,LIU Min,LI Meifang,LI Yulan,WANG Tiejie
关键字: 高效液相色谱法;愈酚维林片;溶出度;浆法;枸橼酸喷托维林;愈创甘油醚
KEYWORDS: HPLC; Pentoxyverine citrate and guaifenesin tablets; Dissolution; Paddle method; Pentoxyverine citrate; Guaifenesin
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