药学学报, 2010, 45(3): 347-352
引用本文:
代秀梅 安 宁 吴健敏 李慧义 张启明. HPLC-UV-MS方法对治疗糖尿病药品或保健品中可能非法添加的4种α-葡糖苷酶抑制剂成分的定性与定量分析[J]. 药学学报, 2010, 45(3): 347-352.
DAI Xiu-Mei, An- Ning, Tun-Jian-Min, Li-Hui-Xi, Zhang-Qi-Meng. Development and validation of HPLC-UV-MS method for the control of four anti-diabetic drugs in suspected counterfeit products[J]. Acta Pharmaceutica Sinica, 2010, 45(3): 347-352.

HPLC-UV-MS方法对治疗糖尿病药品或保健品中可能非法添加的4种α-葡糖苷酶抑制剂成分的定性与定量分析
代秀梅1, 2, 安 宁1*, 吴健敏1, 李慧义3, 张启明1
(1. 中国药品生物制品检定所, 北京 100050; 2. 淄博市药品检验所, 山东 淄博 255086; 3. 国家药典委员会, 北京 100061)
摘要:

本文建立了一种反相高效液相色谱-外光谱检测法, 可同时定量检测维力波糖、米格列醇、维格列波糖和阿卡波糖这4α-葡糖苷酶抑制剂。采用Prevail carbohydrate (250 mm ´ 4.6 mm, 5 μm) 色谱柱, 以乙腈-磷酸盐缓冲液 (pH 8.0) 进行梯度洗脱, 210 nm下进行检测, 结果维力波糖、米格列醇、维格列波糖和阿卡波糖的线性范围分别为58.2932.0 μg·mL−1 (r = 0.9999, n = 5)、23.5376.0 μg·mL−1 (r = 0.999 9, n = 5)0.1282.050 mg·mL−1 (r = 0.999 9, n = 5)38.2612.0 μg·mL−1 (r = 0.999 9, n = 5); 平均回收率分别为97.0%103.6%96.4% 100.4% (n = 9)。与此同时, 本文还建立高相液相色谱-质谱检测方法, 用于这4种化合物的定性分析。以上两种方法简便快捷, 结果准确可靠、重复性好, 可用于可疑的糖尿病药品中非法添加α-葡糖苷酶抑制剂的定性定量检测。

关键词:   
Development and validation of HPLC-UV-MS method for the control of four anti-diabetic drugs in suspected counterfeit products
Abstract:

An HPLC-UV method has been developed for the determination of valibose, miglitol, voglibose and acarbose, the four anti-diabetic drugs.  The separation was accomplished successfully by using reversed phase chromatography (Prevail carbohydrate column, 250 mm ´ 4.6 mm, 5 μm) with a gradient acetonitrile- phosphate buffer solution (pH 8.0) at a wavelength of 210 nm.  Furthermore, the method of a high-performance liquid chromatography coupled with ESI-MS in positive ionization mode has been established.  These two methods were successfully applied to the assay and qualitative detection of four α-glucosidase inhibitors in the potential counterfeit anti-diabetic drugs.

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