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Detection method for dissolution determination of flunarizine hydrochloride capsules

A technology of flunarizine hydrochloride and a detection method, which is applied in the field of analytical chemistry, can solve the problems of unsuitable flunarizine hydrochloride capsule dissolution, reduced column efficiency, shortened chromatographic column life and the like, and achieves low cost and high column efficiency. , the effect of reducing the test cost

Active Publication Date: 2019-12-06
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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  • Detection method for dissolution determination of flunarizine hydrochloride capsules
  • Detection method for dissolution determination of flunarizine hydrochloride capsules
  • Detection method for dissolution determination of flunarizine hydrochloride capsules

Examples

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 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 measuring b...

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 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 (with SDS added): 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 dihydr...

Embodiment 3

[0072] Embodiment 3: the detection method of a kind of flunarizine hydrochloride capsule dissolution assay in the prior art (Comparative 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 hydro...

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Abstract

The invention discloses a detection method for the dissolution determination of flunarizine hydrochloride capsules. The method is characterized in that a dissolution method is a paddle method in whichthe speed is 100 revolutions per minute; a medium of lauryl sodium sulfate is added to serve as a dissolution medium; a dissolved matter is detected by high performance liquid chromatography; octadecyl silane bonded silica gel is taken as a filling agent; the detection wavelength of an ultraviolet detector is 251 to 255nm; the column temperature is 25 to 45 DEG C; the flow rate is 0.9 to 1.1ml / min; and a flowing phase is prepared from methane and a phosphate Buffer solution. Through adoption of the method, the problem concerned with flunarizine hydrochloride capsule filter membrane adsorptionis solved; an obtained chromatographic peak has a good peak pattern; high column efficiency and a more accurate result can be achieved; the service life of a chromatographic column is prolonged; andthe test cost is lowered.

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 Applications(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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