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Method for detecting iodide impurities in amiodarone hydrochloride by high performance liquid chromatography

A high-performance liquid chromatography, amiodarone hydrochloride technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of influence of test results, economical and practical product quality control needs to be further improved, low sensitivity, etc., to achieve cost-effective detection time, quality assurance, and the effect of improving sensitivity

Active Publication Date: 2020-07-17
SHANGHAI XUDONG HAIPU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The sensitivity of the method itself is low, and fluctuations in instruments or other conditions will have a greater impact on the test results, and its economical practicability and product quality control in production testing need to be further improved

Method used

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  • Method for detecting iodide impurities in amiodarone hydrochloride by high performance liquid chromatography
  • Method for detecting iodide impurities in amiodarone hydrochloride by high performance liquid chromatography
  • Method for detecting iodide impurities in amiodarone hydrochloride by high performance liquid chromatography

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of solution

[0034] The preparation of need testing solution: precision measures need testing solution (amiodarone hydrochloride injection, concentration is 50mg / mL) 1.0ml, puts in 10ml brown measuring bottle, dilutes to scale, shakes up and gets final product (about 5mg / mL ml).

[0035] Reference substance stock solution: take about 16.35 mg of potassium iodide reference substance, accurately weigh it, put it in a 100ml brown measuring bottle, add an appropriate amount of diluent, shake to dissolve, and dilute to the mark, shake well to obtain potassium iodide stock solution (about 0.16 mg / ml);

[0036] Preparation of the reference substance solution: Accurately measure 1.0ml of the reference substance stock solution, put it in a 100ml brown measuring bottle, add solvent to dilute to the mark, and shake well to obtain the reference substance solution (1.6 μg / ml).

[0037] Preparation of phosphate buffer solution: Take 7.5 g of potassium dihydrogen phosph...

Embodiment 2

[0047] Embodiment 2 related substance localization test

[0048] Prepare a mixed solution of amiodarone hydrochloride, various related substances and excipients, and make the concentration of impurity A 10 μg, impurity B 10 mg, impurity C 10 μg, impurity D 10 μg, impurity E 10 μg, impurity F 10 μg, impurity A solution of 10 μg of G, 10 μg of auxiliary material H and 10 μg of amiodarone hydrochloride was injected into the liquid chromatograph, and the chromatogram was recorded, such as Figure 4 shown. Iodide impurities can be well separated from other impurities and the main component of amiodarone, and the presence of other impurities does not affect the detection of iodide impurities in amiodarone hydrochloride.

Embodiment 3

[0049] Embodiment 3 Experimental condition screening

[0050] When using the USP method for testing related substances, the specific method is as follows:

[0051] Preparation of acetic acid buffer solution: Add 3 mL of acetic acid to 800 mL of water, adjust the pH to 4.9 with diluted ammonia water, and finally dilute to 1000 mL with water

[0052] Preparation of the solution to be tested: prepare a mixed solution of amiodarone hydrochloride and various related substances (impurity A to impurity G); prepare the solution to contain about 10 μg of impurity A, 10 mg of impurity B, 10 μg of impurity C, 10 μg of impurity D, and 10 μg of impurity E in every 1 ml , a solution of 10 μg of impurity F, 10 μg of impurity G, and 10 μg of amiodarone hydrochloride.

[0053] Instrument: waters e2695 2489UV / 2998PDA high performance liquid chromatography

[0054]Chromatographic column: Inertsil ODS-2-C 18 (150×4.6mm, 5μm)

[0055] Mobile phase: acetonitrile-methanol-acetic acid buffer solu...

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Abstract

The invention discloses a method for detecting iodide impurities in amiodarone hydrochloride, which adopts high performance liquid chromatography. Octadecylsilane chemically bonded silica is taken asa chromatographic column filler, an ultraviolet detector is adopted and a phosphate buffer solution containing 3.5-5.5 PH is taken as a mobile phase, and isogradient elution is carried out. By adopting the novel method for detecting iodide impurities in amiodarone hydrochloride by high performance liquid chromatography, a main drug and related substances can be separated, meanwhile, the interference of various auxiliary materials is reduced, the detection time is saved, the sensitivity of a detection result is improved, and the detection efficiency is improved. According to the method providedby the invention, iodide can be accurately detected, the quality of the amiodarone hydrochloride injection is guaranteed, and the safety of the product is improved.

Description

technical field [0001] The invention relates to an analysis method for detecting iodide impurities in raw materials and injections, in particular to a method for detecting iodide impurities in amiodarone hydrochloride. Background technique [0002] Amiodarone hydrochloride is currently one of the most clinically used antiarrhythmic drugs, which can selectively expand coronary blood flow, reduce myocardial oxygen consumption, slow down heart rate, reduce atrioventricular conduction velocity and β-receptor Blockers have a similar effect. [0003] Amiodarone Hydrochloride Injection, the English name is Amiodarone Hydrochloride Injection, the excipients are 60 mg benzyl alcohol and 80 polysorbate. The indication is to use this product to treat severe arrhythmia when oral administration is not suitable, especially for the following situations: atrial arrhythmia with rapid ventricular rhythm; tachycardia of W-P-W syndrome; severe ventricular arrhythmia; in vitro Cardiopulmonary ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74Y02A50/30
Inventor 赵文芳唐继平杨易可梁屹
Owner SHANGHAI XUDONG HAIPU PHARMA
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