UPLC (Ultra Performance Liquid Chromatography) analysis method of ipratropium bromide aerosol

A technology for analyzing ipratropium bromide and its analysis method, which is applied in the field of analysis of related substances in ipratropium bromide aerosol by ultra-high performance liquid chromatography, and can solve the problem of complex analysis process, low efficiency and long analysis time and other problems, to achieve good stability, good instrument precision, and ensure the effect of clinical efficacy

Active Publication Date: 2021-12-21
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are few bibliographical reports about the content of ipratropium bromide aerosol and related substance analysis methods and all adopt high performance liquid chromatography (HPLC), and the mensuration of content and related substance adopts different chromatographic conditions, analysis process Complex, long analysis time (about 50min), low efficiency

Method used

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  • UPLC (Ultra Performance Liquid Chromatography) analysis method of ipratropium bromide aerosol
  • UPLC (Ultra Performance Liquid Chromatography) analysis method of ipratropium bromide aerosol
  • UPLC (Ultra Performance Liquid Chromatography) analysis method of ipratropium bromide aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Preparation of system suitability solution: Accurately weigh impurity C, ipratropium bromide, impurity B, impurity E, impurity D, impurity EET and impurity F reference substance, impurity B, impurity D and impurity EET are dissolved in 60% acetonitrile,

[0039] The remaining impurities were dissolved in water with a pH of 2.6, mixed and diluted to prepare a system suitability solution containing 100 μg / mL of ipratropium bromide and 0.6 μg / mL of each impurity.

[0040] Preparation of control solution: Accurately weigh impurity C, impurity B, impurity E, impurity D, impurity EET and impurity F reference substance, impurity B, impurity D and impurity EET are dissolved in 60% acetonitrile, and the remaining impurities are dissolved in water with pH 2.6 , mixed and diluted to make a mixed impurity reference solution containing impurity C, impurity EET 0.25 μg / mL, impurity B, impurity E, impurity D, and impurity F 0.3 μg / mL.

[0041]Preparation of the test solution: Accurate...

Embodiment 2

[0046] (1) Specificity experiment

[0047] Precisely measure 7 μL of blank solvent (water at pH 2.6) for injection, record the chromatogram, see figure 2 .

[0048] Strong acid destruction: Take 1 stick of ipratropium bromide aerosol in Example 1, and transfer it to a 50mL volumetric flask after evaporating the propellant through the conical hole, add 0.1mol / L hydrochloric acid 2mL, leave it at room temperature for 2h, add 0.1mol / L After neutralizing to the original pH value with L sodium hydroxide, dilute the water with pH 2.6 to the mark to obtain the acid-destroyed sample solution. Get this sample solution 7 μ L sample injection, chromatographic conditions are the same as embodiment 1, record chromatogram, strong acid destroys sample solution chromatogram see Figure 6 . The results are shown in Table 1.

[0049] Take 1 stick of ipratropium bromide aerosol of Example 1, and transfer it to a 50mL volumetric flask after evaporating the propellant through the conical hole...

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Abstract

According to the UPLC analysis method for determining the ipratropium bromide aerosol, the analysis efficiency is remarkably improved, and the detection process is completed within 8 minutes. According to the method, ultra-high performance liquid chromatography is adopted, and the chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filler; a sodium heptanesulfonate aqueous solution (A) with a pH value of 2.6 and acetonitrile (B) with a ratio of 72: 28 are taken as a mobile phase; the detection wavelength is 210 nm; the column temperature is 40 DEG C; the flow velocity is 0.6 ml / min; and isocratic elution is carried out.

Description

technical field [0001] The invention relates to the technical field of ultra-high performance liquid chromatography, in particular to an analysis method for determining related substances in ipratropium bromide aerosol by adopting ultra-high performance liquid chromatography. Background technique [0002] Bronchial asthma in children is a common respiratory disease that seriously endangers children's health. It has a high incidence rate, a long course and repeated attacks. The probability of asthma attack during sleep is about 188 times that during activity, and it has a similar circadian rhythm, and the best time for administration is at 4 o'clock in the morning. This phenomenon has brought a lot of inconvenience for children medication. [0003] Ipratropium bromide, chemical name [(1R,5S)-8-methyl-8-isopropyl-8-azabicyclo[3.2.1]oct-3-yl]3-hydroxy -2-Phenylpropionate bromide, the chemical structure of which is as follows: [0004] [0005] Ipratropium bromide is an an...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8631Y02E30/30
Inventor 肖超强高茹梦杨秀云安杨王建村杨杰何淑旺张威风张颖
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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