CN Patent

CN109781920B — 一种坎格雷洛有关物质的hplc检测方法

Assigned to CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co Ltd · Expires 2023-07-11 · 3y expired

What this patent protects

本发明提供了一种坎格雷洛有关物质的高效液相色谱检测方法:采用反相色谱柱;填充剂为十八烷基键合硅胶;以磷酸盐高氯酸钠缓冲溶液为流动相A,乙腈为流动相B,梯度洗脱。该方法专属性强,灵敏度高,定量测定结果准确;分析方法简便快速,在较短时间内可以较好分离全部杂质,各色谱峰之间的分离度均大于1.5,可全面检测坎格雷洛及其制剂中的有关物质,提高药品安全性,为制定坎格雷洛原料药和制剂的质量标准提供依据。

USPTO Abstract

本发明提供了一种坎格雷洛有关物质的高效液相色谱检测方法:采用反相色谱柱;填充剂为十八烷基键合硅胶;以磷酸盐高氯酸钠缓冲溶液为流动相A,乙腈为流动相B,梯度洗脱。该方法专属性强,灵敏度高,定量测定结果准确;分析方法简便快速,在较短时间内可以较好分离全部杂质,各色谱峰之间的分离度均大于1.5,可全面检测坎格雷洛及其制剂中的有关物质,提高药品安全性,为制定坎格雷洛原料药和制剂的质量标准提供依据。

Drugs covered by this patent

Patent Metadata

Patent number
CN109781920B
Jurisdiction
CN
Classification
Expires
2023-07-11
Drug substance claim
No
Drug product claim
No
Assignee
CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co Ltd
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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