| 第 46 卷第 5 期 |  | Vol. 46 No. 5 | | 2016 年 10 月 | Oct 2016 |
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所屬欄目：分析與測試
雷貝拉唑鈉腸溶膠囊（微丸型）的HPLC分析 |
| 謝 斌1，2，3，4，周 建1，朱小慶1，馮偉霞1，張 武1，黃俊鵬1，關(guān) 東1，陳新民1，2，3，4
（1. 珠海潤都制藥股份有限公司，廣東 珠海 519041；2. 珠海潤都制藥股份有限公司博士后科研工作站，廣東 珠海 519041；3. 廣東省工程技術(shù)研究中心，廣東 珠海 519041；4. 珠海市微丸制劑技術(shù)研究中心，廣東 珠海 519041） |
| 摘 要：建立HPLC法測定雷貝拉唑鈉腸溶膠囊（微丸型）的有關(guān)物質(zhì)。 采用Agilent ZORBAX（4.6 mm×250 mm，5 μm）色譜柱，流動(dòng)相采用0.015 mol／L磷酸氫二鈉溶液（用磷酸調節pH值至6.0）-乙腈（v∶v=65∶35），等度洗脫，流速為1.0 mL／min，柱溫：30℃，檢測波長(cháng)為290 nm。該色譜條件下，主成份與已知雜質(zhì)分離度良好。雷貝拉唑鈉的檢測限為3.3 μg／mL，定量限為10 μg／mL，是供試品進(jìn)樣量的0.33%和1.00%，滿(mǎn)足雜質(zhì)檢測和控制。通過(guò)穩定性的考察，供試品溶液不穩定，需要現用現配。該方法簡(jiǎn)單、快速、準確，可用于雷貝拉唑鈉腸溶膠囊（微丸型）的質(zhì)量控制。 |
| 關(guān)鍵詞：高效液相色譜法；雷貝拉唑鈉腸溶膠囊（微丸型）；有關(guān)物質(zhì) |
| 中圖分類(lèi)號：Q657.7+2 文獻標識碼：A 文章編號：1009-9212（2016）05-0063-04 |
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| Determination of Rabeprazole Sodium Enteric-coated Capsules (micro pill) |
| XIE Bin1,2,3,4, ZHOU Jian1, ZHU Xiao-qing1, FENG Wei-xia1, ZHANG Wu1, HUANG Jun-peng1, GUAN Dong1, CHEN Xin-min1,2,3,4
(1. Zhuhai Rundu Pharmaceutical Co., Ltd., Zhuhai 519041, China; 2. Postdoctoral Science Research Workstation of Zhuhai Rundu Pharmaceutical Co., Ltd., Zhuhai 519041, China; 3. Guangdong Engineering and Technology Research Center, Zhuhai 519041, China; 4. Zhuhai Technology Research Center for Pellets Formulation, Zhuhai 519041, China) |
| Abstract：A HPLC method for the determination of related substances in rabeprazole sodium was established.The determination was performed on an Agilent ZORBAX(4.6 mm×250 mm, 5 μm) column. The mobile phase consisted of 0.015 mol/L Sodium phosphate dibasic (adjusted pH value 6 with phosphoric acid)-acetonitrile(65:35). Other conditions for the separation were including isocratic elution, a flow rate of 1 mL/min, column temperature of 30℃, detection wavelength of 290 nm. Ralated substances were completely separated from the main constituent. The detection limit for rabeprazole was 3.3 μg/mL and the quantification limit was 10 μg/mL, which were 0.33% and 1.00% of test sample,respectively. The solution is not stable, it needed to be used at present. The method simple, rapid and accurate, and can be used to control the quality of rabeprazole sodium enteric-coated pellets. |
| Key words：HPLC; rabeprazole sodium enteric-coated capsules (micro pill); ralated substances |
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作者簡(jiǎn)介：謝 斌（1975-），男，安徽宿州人，副研究員，博士，研究方向：新藥研究與開(kāi)發(fā)（E-mail：42276143 @qq.com）。
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收稿日期： 2016-07-2
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