Method for detecting releasing rate of amantadine hydrochloride sustained release tablets

A technology for amantadine and its detection method, which is applied in the release detection field of memantine hydrochloride sustained-release tablets, can solve the problems of low detection sensitivity, and achieve the effects of high sensitivity, strong practicability, and good reproducibility

Inactive Publication Date: 2014-12-24
SHANDONG INST OF PHARMA IND
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Problems solved by technology

Dissolve memantine hydrochloride in methanol and prepare a solution containing 5.0mg per

Method used

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Embodiment 1

[0018] 1. Chromatographic conditions and system suitability test:

[0019] 1.1. Selection of detection instruments: Since the structure of this product is relatively stable and there is no chromophore, this product has no absorption in the ultraviolet region. Dissolve the memantine hydrochloride test sample with methanol and prepare a solution containing 5.0mg per 1ml, and select the detection wavelength of 205nm, the detection sensitivity is still low, therefore, in order to better detect impurities and better control product quality , we chose an evaporative light scattering detector.

[0020] 1.2. Selection of chromatographic conditions:

[0021] Instruments: SHIMADZU LC-10AT VP, Alltech ELSD 2000, 717 Plus Auto sampler. The temperature range of the ELSD drift tube is 70-130°C, and the optimum detection temperature is 100°C; the nitrogen flow rate is 2.0-2.5L / min. The liquid chromatographic column uses octadecyl bonded silica gel as filler (4.6mmX250mm, 5μm). Referring t...

Embodiment 2

[0030] Embodiment two: the mensuration of amantadine hydrochloride sustained-release tablet

[0031] Take three batches of each six tablets of this product, according to the release assay method (Chinese Pharmacopoeia 2010 edition two appendix XC third method), with 0.1mol / L hydrochloric acid solution 100ml as solvent, rotating speed is 75 revolutions per minute, operate according to law, in After 1 hour, 2 hours, 4 hours, and 8 hours, take 5ml of the solution respectively, take an appropriate amount of the solution, filter, and take the continued filtrate as the test solution. In addition, an appropriate amount of memantine hydrochloride reference substance was accurately weighed, and a solution containing about 0.1 mg of memantine hydrochloride per 1 ml was made by the same method as the reference substance solution. Under the following selected chromatographic conditions: HPLC-ELSD detector (SHIMADZU LC-10AT VP, Alltech ELSD 2000, 717 Plus Auto sampler), using octadecyls...

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Abstract

The invention discloses a method for detecting the releasing rate of amantadine hydrochloride sustained release tablets. The method comprises the steps of under chromatographic conditions that a high performance liquid chromatograph-evaporative light-scattering detector is adopted and methyl alcohol-acetonitrile-isopropanol-aqueous solution (in a ratio of 50:20:20:10) is taken as a flowing phase, processing six units of amantadine hydrochloride sustained release tablets with 100ml of 0.1mol/L hydrochloric acid solution as a releasing medium at a rotating speed of 75r/min according to a dissolution rate measurement method, taking 5ml of solution after one hour, two hours, four hours and eight hours respectively, filtering the extracted solution while supplementing the solution by 5ml in time, and measuring subsequent filtrate to obtain a test solution; adding water into a contrast to prepare a 0.1mg/ml solution serving as a contrast solution; and recording chromatogram maps of the two solutions, wherein the volume of each solution is 20 microliter. According to the releasing rate detection method, the defect that memantine hydrochloride with a relatively stable structure cannot be effectively detected as being free of absorption in an ultraviolet region is overcome; under a simple flowing phase condition, the dissolving rate of memantine hydrochloride can be accurately detected; the releasing rate detection method has the advantages of simplicity, quickness and accuracy.

Description

technical field [0001] The invention relates to a method for detecting the release degree of memantidine hydrochloride sustained-release tablets, which belongs to the field of drug analysis and detection. Background technique [0002] Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist, which is mainly used for the treatment of Alzheimer's disease (senile dementia) by delaying the release of excitatory neurotransmitter glutamate ). This project is an improved dosage form of memantine hydrochloride tablets already on the market. The main skeleton component in the prescription is HPMC, the auxiliary component is calcium hydrogen phosphate, and the binder is povidone. The structure of the raw material drug of this product is relatively stable, and there is no chromophoric group, so this product has no absorption in the ultraviolet region. Dissolve memantine hydrochloride in methanol and prepare a solution containing 5.0 mg per 1 ml, and select a dete...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/74
Inventor 张岱州李玉基李洁王功霞曹冲
Owner SHANDONG INST OF PHARMA IND
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