Unlock instant, AI-driven research and patent intelligence for your innovation.

Method for detection of related substances in fasudil hydrochloride raw materials or injections

A technology of fasudil hydrochloride and detection method, which is applied in the field of drug analysis, can solve the problems of extensive and single, and achieve the effects of high accuracy, good repeatability and high sensitivity

Active Publication Date: 2021-06-29
KPC PHARM INC
View PDF8 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Some of the existing methods for detecting related substances of Fasudil hydrochloride are too simple and only detect a certain impurity component, while others are too extensive and only consider the relationship between the largest single impurity, total impurity and the main components of Fasudil hydrochloride

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for detection of related substances in fasudil hydrochloride raw materials or injections
  • Method for detection of related substances in fasudil hydrochloride raw materials or injections
  • Method for detection of related substances in fasudil hydrochloride raw materials or injections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] The first part is a method for analyzing and controlling the limits of six impurities (impurity 1, impurity 3, impurity 5, impurity 8, impurity 9, and impurity 10) in fasudil hydrochloride raw materials and its preparations using high performance liquid chromatography. Including the following steps:

[0065] (1) get fasudil hydrochloride raw material to dissolve with diluent and be diluted to the solution that every 1ml contains fasudil hydrochloride 0.5mg, as need testing solution.

[0066] (2) Dissolve each impurity (impurity 3, impurity 5, impurity 8, impurity 9 and impurity 10) with a diluent and dilute to a solution containing 5 μg of impurity per 1 ml as impurity stock solution.

[0067] (3) Accurately weigh about 5 mg of fasudil hydrochloride, put it in a 10 ml measuring bottle, accurately pipette 1.0 ml of the impurity stock solution, dissolve it with a diluent and dilute to the mark, shake well, and use it as a system suitability solution.

[0068] (4) Fasudil...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to the technical field of drug analysis, in particular to a method for detecting related substances in fasudil hydrochloride raw materials or injections. The invention provides a method for quantitatively detecting active ingredients and synthetic by-products in fasudil hydrochloride raw materials or preparations by using an HPLC method. The method provided by the invention has high accuracy, high sensitivity and good repeatability. Experiments have shown that in the detection of general impurities, the RSD value of the peak area of ​​5 needles continuously injected by the method provided by the invention does not exceed 5%, and in the detection of genotoxic impurities, the RSD value of the peak area of ​​5 needles does not exceed 10%. , the error among multiple sampling test results is small, the test data is in line with the expected value, and the minimum detection limits for Fasudil hydrochloride and its related substances are all lower than the quality control requirements.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting related substances in fasudil hydrochloride raw materials or injections. Background technique [0002] Fasudil hydrochloride is a new type of drug with a wide range of pharmacological effects. Its molecular structure is a 5-isoquinoline sulfonamide derivative, which is an RHO kinase inhibitor and expands blood vessels by increasing the activity of myosin light chain phosphatase , reduce the tension of endothelial cells, improve the microcirculation of brain tissue, prevent and aggravate cerebral blood stealing, and at the same time antagonize inflammatory factors, protect nerves against apoptosis, and promote nerve regeneration. The results show that fasudil hydrochloride has a certain effect on promoting the recovery of nerve function, relieving clinical symptoms and reducing the disability rate. [0003] In the process of synthesizing this compound...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/34G01N30/86
CPCG01N30/34G01N30/8634
Inventor 高宏涛杨建玲宋立明朱泽刘世成陈云建
Owner KPC PHARM INC