HPLC测定复方头孢克洛胶囊含量、含量均匀度及溶出度的研究.docVIP

HPLC测定复方头孢克洛胶囊含量、含量均匀度及溶出度的研究 　　【摘要】 目的：建立测定复方头孢克洛胶囊含量、含量均匀度及溶出度的高效液相色谱法。方法：采用Waters Shield RP C18色谱柱（4.6 mm×250 mm，5 μm），以乙腈-0.025 mol/L磷酸二氢钾溶液（用磷酸调节pH值至3.0）（22：78）为流动相，流速1.0 mL/min，柱温30 ℃，检测波长249 nm。结果：含量、含量均匀度中头孢克洛和盐酸溴己新的线性范围分别为280.97～842.90 μg/mL（r=1.0000）和11.00～33.01 μg/mL（r=1.0000）；复方头孢克洛胶囊中头孢克洛和溴己新平均回收率（n=3）分别为99.8%、100.3%（RSD为0.25%、0.86%）和101.2%、100.4%（RSD为0.47%、0.98%）；溶出度中头孢克洛和盐酸溴己新的线性范围分别为141.71～472.38μg/mL（r=0.9991）和4.83～14.53 μg/mL（r=0.9991）；复方头孢克洛胶囊中头孢克洛和溴己新平均回收率（n=3）分别为99.6%、100.2%（RSD为0.22%、0.64%）和100.8%、99.9%（RSD为0.72%、0.47%）。样品检测结果显示，复方头孢克洛胶囊中头孢克洛和溴己新含量均匀度均良好，胶囊在30 min取样，头孢克洛溶出量达到90%以上，溴己新溶出量达到70%以上。结论：建立的HPLC法具有专属性强、灵敏度高、操作简便等特点，可同时考察头孢克洛和盐酸溴己新含量、含量均匀度及溶出度，可进一步有效控制药品质量。 　　【关键词】 复方头孢克洛胶囊； 含量测定； 含量均匀度； 溶出度； 高效液相色谱法 　　【Abstract】 Objective： To establish an HPLC method for determination of content ，uniformity and dissolution of Compound cefaclor capsules.Method： Waters shield RP C18 column （4.6 mm×250 mm，5μm）was used， the mobile phase was acetonitrile -0.025 mol/L potassium dihydrogen phosphate （adjusted to pH 3.0 with phosphoric acid） （22：78） at a folw rate of 1.0 mL/min， the column temperature was 30 ℃ and detection wavelength was 249 nm. Result： The good linearity for Cefaclor and Bromhexine hydrochloride of content， uniformity were 280.97-842.90 μg/mL（r=1.0000）and 11.00-33.01 μg/mL（r=1.0000）； the average recoveries （n=3） for Cefaclor and Bromhexine of Compound cefaclor capsules were 99.8%， 100.3% with RSD of 0.25%， 0.86% and 101.2%， 100.4% with RSD of 0.47%， 0.98%； the good linearity for Cefaclor and Bromhexine hydrochloride of dissolution were 141.71-472.38 μg/mL（r=0.9991）and 4.83-14.531 μg/mL（r=0.9991）；the average recoveries （n=3） for Cefaclor and Bromhexine hydrochloride of Compound cefaclor capsules were 99.6%， 100.2% with RSD of 0.22%， 0.64% and 100.8%， 99.9% with RSD of 0.72%， 0.47%. The content uniformities for Cefaclor and Bromhexine of compound cefaclor capsules were good， the drug dissolution at 30 min， cefaclor was above 80% and br