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注射用生长抑素的原企业标准无相关肽的测定且企业标准中的含量测定方法不能有效地分离样品中的相关肽,本文所述方法通过梯度洗脱解决了上述问题,并且用自身对照溶液限定了相关肽的含量,方法直观,可行。 1.方法与结果 1.1 药品与试剂 生长抑素对照品(法国赛诺菲集团提供),注射用生长抑素(法国赛诺菲集团提供),85％磷酸(优级纯),三乙胺(分析纯),乙腈(色谱纯),重蒸去离子水。 1.2 仪器与色谱条件 色谱仪:HP1100型全自动液相色谱仪;检测器:紫外检
The original enterprise standard for somatostatin for injection has no relevant peptide assay and the method of content determination in the enterprise standard can not effectively separate related peptides in the sample. The method described herein solves the above problems by gradient elution, and uses the self-control solution The content of related peptide is limited, and the method is intuitive and feasible. 1. Methods and Results 1.1 Drugs and reagents Somatostatin reference substance (provided by the French Sanofi Group), injection of somatostatin (provided by the French Sanofi Group), 85% phosphoric acid (excellent grade pure), triethylamine ( Analytical purity), Acetonitrile (Chromatography pure), Heavy distilled deionized water. 1.2 Instruments and chromatographic conditions Chromatograph: HP1100-based automatic liquid chromatography; detector: UV