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Method for synchronously detecting five related substances in compound ipratropium bromide solution for inhalation

A technology of ipratropium bromide and related substances, which is applied in the field of simultaneous detection of five related substances in the compound ipratropium bromide solution for inhalation, can solve the problem of inability to guarantee the measurement sensitivity and specificity, and the inability of related substances and main components Separation, complex components, etc., to avoid changing liquid phase conditions, stable and reliable results, and simple operation

Active Publication Date: 2020-09-29
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method detects the content of the two components of compound albuterol, it does not further measure the content of related substances, and because the composition of related substances is complex, this method cannot significantly distinguish the related substances from the main components. Separate, and does not guarantee the sensitivity and specificity of the measurement

Method used

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  • Method for synchronously detecting five related substances in compound ipratropium bromide solution for inhalation
  • Method for synchronously detecting five related substances in compound ipratropium bromide solution for inhalation
  • Method for synchronously detecting five related substances in compound ipratropium bromide solution for inhalation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Instruments and conditions: Waters liquid chromatography system, 2998 detector, chromatographic column: Waters Xbridge C18 (150×4.6mm, 3.5μm); detection wavelength: 210nm; pH adjustment with phosphoric acid in buffer containing 0.006mol / L sodium heptanesulfonate To 2.5 is the mobile phase A, acetonitrile is used as the mobile phase B, the detection wavelength is 210nm, the column temperature is 35°C, and the flow rate is 1.0ml / min.

[0037] In terms of volume ratio, the setting of the gradient elution is:

[0038]

[0039] experiment procedure:

[0040] Among them, ipratropium bromide and its related impurity reference substance were purchased from Zhejiang Youlian Pharmaceutical Chemical Co., Ltd.; salbutamol sulfate and its related impurity reference substance were purchased from Beijing Huawei Ruike Chemical Co., Ltd.; Produced by New Times Pharmaceutical Co., Ltd. (batch number 06418003).

[0041] Take ipratropium bromide, salbutamol sulfate, ipratropium bromid...

Embodiment 2

[0067] Embodiment 2 specificity experiment

[0068] Instruments and conditions: Waters liquid chromatography system, 2998 detector, chromatographic column: Waters Xbridge C18 (150×4.6mm, 3.5μm); detection wavelength: 210nm; pH adjustment with phosphoric acid in buffer containing 0.006mol / L sodium heptanesulfonate To 2.5 is the mobile phase A, acetonitrile is the mobile phase B, the detection wavelength is 210nm, the column temperature is 35°C, and the flow rate is 1.0ml / min.

[0069] In terms of volume ratio, the setting of the gradient elution is:

[0070]

[0071] 1. The compound ipratropium bromide solution blank adjuvant for inhalation (from Shandong New Times Pharmaceutical Co., Ltd.), is determined according to the method of Example 2, and the HPLC spectrum is shown in the appendix Figure 5 .

[0072] Depend on Figure 5 It can be seen that the blank excipients have no interference to the determination of related substances in the samples.

[0073] 2. Determinati...

Embodiment 3

[0075] Embodiment 3 method durability test

[0076] Instruments and conditions: Waters liquid chromatography system, 2998 detector, chromatographic column: Waters Xbridge C18 (150×4.6mm, 3.5μm); detection wavelength: 215nm; pH adjustment with phosphoric acid in buffer containing 0.006mol / L sodium heptanesulfonate To 2.5 is the mobile phase A, methanol is the mobile phase B, the column temperature is 30°C, and the flow rate is 0.9ml / min.

[0077] In terms of volume ratio, the setting of the gradient elution is:

[0078]

[0079] Take ipratropium bromide, albuterol sulfate, ipratropium bromide impurity C, albuterol impurity B, albuterol impurity C, albuterol impurity D, albuterol impurity F and prepare 10 μg each with heptanesulfonate sodium phosphate buffer solution-methanol mixed solution / ml of the mixed solution, accurately measure 25 μl into the liquid chromatograph, and record the chromatogram.

[0080] Under this condition, the retention time of the main peak of ipra...

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Abstract

The invention relates to a method for synchronously detecting five related substances in a compound ipratropium bromide solution for inhalation, and belongs to the technical field of drug quality determination methods. High performance liquid chromatography is adopted for detection, a chromatographic column with alkyl bonded silica gel is adopted as a filler, a phosphate buffer solution containingsodium heptanesulfonate is used as a mobile phase A, an organic phase is used as a mobile phase B, and a detection wavelength is 205-300nm. The detection method provided by the invention can effectively separate ipratropium bromide and salbutamol sulfate from other impurities, and has characteristics of simple operation, a comprehensive result, accuracy, reliability and strong specificity.

Description

technical field [0001] The invention relates to the technical field of drug quality determination methods, in particular to a method for synchronous detection of five related substances in a compound ipratropium bromide solution for inhalation. Background technique [0002] Compound ipratropium bromide solution for inhalation is a colorless or almost colorless clear liquid, and its main components are ipratropium bromide and salbutamol sulfate. This product is suitable for patients who need a combination of multiple bronchodilators for the treatment of reversible bronchospasm associated with airway obstructive diseases. Among them, ipratropium bromide and salbutamol act superimposed on muscarinic and β2 adrenergic receptors in the lungs to produce bronchodilation, and the curative effect is better than single administration. [0003] In the article "Determination of Related Substances in Ipratropium Bromide Solution for Inhalation by Reversed-Phase High Performance Liquid C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/36
CPCG01N30/02G01N30/36Y02A50/30
Inventor 张贵民郭小为刘阿利
Owner LUNAN PHARMA GROUP CORPORATION
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