A kind of detection method for dissolution determination of flunarizine hydrochloride capsules

A flunarizine hydrochloride and detection method technology, which is applied in the field of analytical chemistry, can solve the problems of reduced column efficiency, dissolution of flunarizine hydrochloride capsules that are no longer applicable, and reduced life of the chromatographic column, achieving high column efficiency and low cost , the effect of reducing the test cost

Active Publication Date: 2022-03-22
贵州缔谊健康制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But in the study of pH6.8+0.4%SDS medium stripping curve, when using potassium dihydrogen phosphate as the mobile phase of salt, it will react with sodium lauryl sulfate in the solvent of the test product, so that the chromatographic peak can be separated Fork, reduced column efficiency, reduced column life
Combined with the influence of filter membrane adsorption, this method is no longer suitable for the dissolution study of flunarizine hydrochloride capsules, regardless of the accuracy of the results or economic considerations

Method used

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  • A kind of detection method for dissolution determination of flunarizine hydrochloride capsules
  • A kind of detection method for dissolution determination of flunarizine hydrochloride capsules
  • A kind of detection method for dissolution determination of flunarizine hydrochloride capsules

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: A kind of detection method of flunarizine hydrochloride capsule dissolution assay

[0041] Instruments and Conditions:

[0042] High performance liquid chromatography: DIONEXU3000;

[0043] Chromatographic column: YMC-PackODSC18 (4.6*250mm, 5μm);

[0044] Mobile phase: Methanol-phosphate buffer (take 1.20 g of sodium dihydrogen phosphate, add water to dissolve and dilute to 1000 ml, add 4 ml of triethylamine, adjust the pH value to 3.5 with phosphoric acid) (75:25);

[0045] Column temperature: 35°C;

[0046] Flow rate: 1.0ml / min;

[0047] Detection wavelength: 253nm;

[0048] Injection volume: 20 μl.

[0049] Implementation steps:

[0050] (1) Preparation of dissolution medium: Weigh 2.00 g of SDS, 6.00 g of sodium dihydrogen phosphate (7.80 g of sodium dihydrogen phosphate dihydrate), 0.90 g of sodium hydroxide, and dilute with water to 1000 ml.

[0051](2) Take 10.89mg and 11.02mg of flunarizine hydrochloride as control, put them in a 100ml measu...

Embodiment 2

[0054] Embodiment 2: a kind of detection method of flunarizine hydrochloride capsule dissolution assay:

[0055] Instruments and Conditions:

[0056] High performance liquid chromatography: DIONEXU3000;

[0057] Chromatographic column: YMC-PackODSC18 (4.6*250mm, 5μm);

[0058] Mobile phase: Methanol-phosphate buffer (take 1.20 g of sodium dihydrogen phosphate, add water to dissolve and dilute to 1000 ml, add 4 ml of triethylamine, adjust the pH value to 3.5 with phosphoric acid) (75:25);

[0059] Column temperature: 35°C;

[0060] Flow rate: 1.0ml / min;

[0061] Detection wavelength: 253nm;

[0062] Injection volume: 20 μl.

[0063] Implementation steps:

[0064] (1) Preparation of dissolution medium (adding SDS): Weigh 2.00 g of SDS, 6.00 g of sodium dihydrogen phosphate (7.80 g of sodium dihydrogen phosphate dihydrate), 0.90 g of sodium hydroxide, and dilute to 1000 ml with water.

[0065] (2) Preparation of dissolution medium (without SDS): Weigh 6.00 g of sodium dihy...

Embodiment 3

[0072] Embodiment 3: the detection method of a kind of flunarizine hydrochloride capsule dissolution assay in the prior art (comparison case)

[0073] Instruments and Conditions:

[0074] High performance liquid chromatography: DIONEX U3000;

[0075] Chromatographic column: YMC-Pack ODS C18 (4.6*250mm, 5μm);

[0076] Mobile phase: methanol-phosphate buffer (take 1.36g of potassium dihydrogen phosphate, add water to dissolve and dilute to 1000ml, add 4ml of triethylamine, adjust the pH value to 3.5 with phosphoric acid) (75:25);

[0077] Column temperature: 35°C;

[0078] Flow rate: 1.0ml / min;

[0079] Detection wavelength: 253nm;

[0080] Injection volume: 20 μl.

[0081] Implementation steps:

[0082] (1) Preparation of dissolution medium: Weigh 2.00 g of SDS, 6.00 g of sodium dihydrogen phosphate (7.80 g of sodium dihydrogen phosphate dihydrate), 0.90 g of sodium hydroxide, and dilute with water to 1000 ml.

[0083] (2) Take 11.13mg and 11.35mg of flunarizine hydroc...

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Abstract

The invention discloses a detection method for the dissolution determination of flunarizine hydrochloride capsules. The method is as follows: the dissolution method is the paddle method, 100 revolutions per minute, and the medium with sodium lauryl sulfate is added as the dissolution medium; high-efficiency liquid phase Chromatographic detection of dissolved matter, with octadecylsilane bonded silica gel as filler; UV detector, detection wavelength is 251-255nm; column temperature is 25-45°C; flow rate is 0.9-1.1ml / min; mobile phase is Methanol and Phosphate Buffers. The method of the invention solves the adsorption problem of the flunarizine hydrochloride capsule filter membrane, and the obtained chromatographic peak shape is good, the column efficiency is high, the obtained result can be made more accurate, the service life of the chromatographic column is prolonged, and the test cost is reduced .

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry, and in particular relates to a detection method for the dissolution determination of flunarizine hydrochloride capsules. Background technique [0002] Flunarizine Hydrochloride Capsules is a vasodilator drug, mainly used for the prevention and treatment of typical or atypical migraine and the symptomatic treatment of vertigo caused by vestibular dysfunction. [0003] Flunarizine hydrochloride is a selective calcium antagonist, which can block excessive calcium ions from transmembrane into cells and prevent excessive intracellular calcium load. It can also prevent a large amount of calcium from entering neurons during ischemia and hypoxia, improve brain microcirculation and neuron metabolism, inhibit cerebral vasospasm, platelet aggregation and increased blood viscosity, etc. In addition, it also has a stabilizing effect on pleural membranes. This product is highly fat-soluble and ea...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74
CPCG01N30/02G01N30/06G01N30/74
Inventor 李文博曲永战魏佳康爽甄晓昱韦斌孙晓军张徐艳肖梦万小碎鄢玉芬
Owner 贵州缔谊健康制药有限公司
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