CN Patent

CN116678964B — 糠酸莫米松鼻喷雾剂有关物质检测方法

Assigned to Zhejiang Cuize Pharmaceutical Technology Co ltd · Expires 2026-01-30 · 0y expired

What this patent protects

本发明公开了一种糠酸莫米松鼻喷雾剂有关物质检测方法,选用十八烷基硅烷键合硅胶填充的色谱柱,以0.02mol/L高氯酸钠为流动相A,以乙腈为流动相B,进行梯度洗脱,流速为0.8~1.2mL/min,检测波长为240nm‑260nm,柱温30~50℃,进样量为10~25μL;其中,所述流动相A与所述流动相B的体积份之和为100,且洗脱第0min时,所述流动相A的体积份为57~59。本发明方法能够同时检测光降解未知杂质,辅料出峰位置基线平缓不影响杂质定量,防腐剂完全洗脱,精密度和耐用性好,同时提高了检测灵敏度,缩短了检测时间,操作简单、专属性高、抗干扰性强。

USPTO Abstract

本发明公开了一种糠酸莫米松鼻喷雾剂有关物质检测方法,选用十八烷基硅烷键合硅胶填充的色谱柱,以0.02mol/L高氯酸钠为流动相A,以乙腈为流动相B,进行梯度洗脱,流速为0.8~1.2mL/min,检测波长为240nm‑260nm,柱温30~50℃,进样量为10~25μL;其中,所述流动相A与所述流动相B的体积份之和为100,且洗脱第0min时,所述流动相A的体积份为57~59。本发明方法能够同时检测光降解未知杂质,辅料出峰位置基线平缓不影响杂质定量,防腐剂完全洗脱,精密度和耐用性好,同时提高了检测灵敏度,缩短了检测时间,操作简单、专属性高、抗干扰性强。

Drugs covered by this patent

Patent Metadata

Patent number
CN116678964B
Jurisdiction
CN
Classification
Expires
2026-01-30
Drug substance claim
No
Drug product claim
No
Assignee
Zhejiang Cuize Pharmaceutical Technology 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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