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Method for detecting cyclobenzaprine hydrochloride sustained-release capsules

A technology of cyclobenzaprine hydrochloride and sustained-release capsules, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of low accuracy and repeatability, and few detection methods, and achieve strong specificity and good reproducibility , good accuracy and precision

Inactive Publication Date: 2020-09-25
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Due to the particularity of cyclobenzaprine hydrochloride sustained-release capsules, there are few detection methods for the raw material drug cyclobenzaprine hydrochloride in cyclobenzaprine hydrochloride sustained-release capsules in the prior art, and there are generally problems with low accuracy and repeatability. question

Method used

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  • Method for detecting cyclobenzaprine hydrochloride sustained-release capsules
  • Method for detecting cyclobenzaprine hydrochloride sustained-release capsules
  • Method for detecting cyclobenzaprine hydrochloride sustained-release capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 needs testing solution preparation

[0028] Take 1 cyclobenzaprine hydrochloride sustained-release capsule (15mg), pour all the contents into a 25ml (15mg specification) measuring bottle, add 5ml of methanol, shake for 5 minutes, add 10ml of water, and ultrasonically make cyclobenzaprine hydrochloride Dissolve, add water to dilute to the mark, shake well, filter, accurately measure 2ml of the continued filtrate, put it in a 50ml measuring bottle, add water to dilute to the mark, shake well, and use it as the test solution.

Embodiment 2

[0029] Example 2 Preparation of reference substance solution

[0030] Accurately weigh 30mg of cyclobenzaprine hydrochloride reference substance, put it in a 50ml measuring bottle, add 2ml of methanol, add an appropriate amount of water to dissolve, add water to dilute to the mark, shake well, accurately measure 2ml, put it in a 50ml measuring bottle, add water to dilute to Scale, shake well, as a reference solution.

Embodiment 3

[0031] Example 3 Establishment of detection method

[0032] (1) Linear range and regression equation

[0033] Accurately weigh 30.94mg of cyclobenzaprine hydrochloride reference substance, put it in a 50ml measuring bottle, add 2ml of methanol, add an appropriate amount of water to dissolve, add water to dilute to the mark, shake well, and accurately measure 1.2, 1.6, 2.0, 2.4, 2.8ml , put them in five 50ml measuring bottles respectively, add water to dilute to the mark, shake well, respectively accurately measure 20 μl of the above-mentioned series of solutions, inject them into a liquid chromatograph, record the chromatograms, draw a curve with the peak area versus the concentration, and calculate by the least squares method The regression equation and correlation coefficient are shown in Table 1.

[0034] Table 1 Concentration and corresponding peak area of ​​cyclobenzaprine hydrochloride

[0035]

[0036] Regression equation: Amount=2.650e -005 ×Area-2.922e -001

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Abstract

The invention relates to a detection method of cyclobenzaprine hydrochloride sustained-release capsules, and belongs to the field of pharmaceutical analysis. According to the detection method of cyclobenzaprine hydrochloride sustained-release capsules, cyclobenzaprine hydrochloride is detected through an HPLC method. According to the detection method disclosed by the invention, the cyclobenzaprinehydrochloride is good in linear relationship, good in accuracy and precision, strong in specificity and high in stability. The detection method has good reproducibility, can meet the detection requirements of cyclobenzaprine hydrochloride bulk drugs, and can be used for quality control of cyclobenzaprine hydrochloride sustained-release capsules.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a detection method for cyclobenzaprine hydrochloride sustained-release capsules. The detection method has good reproducibility, can meet the detection requirements of cyclobenzaprine hydrochloride sustained-release capsules, and can be used for quality control of cyclobenzaprine hydrochloride sustained-release capsules. Background technique [0002] Cyclobenzaprine hydrochloride, the chemical name is 5-(3-dimethylaminopropene) dibenzo[a,e] cycloheptatriene hydrochloride, the structural formula is: [0003] [0004] Molecular formula: C 20 h 21 N·HCl [0005] Molecular weight: 311.85 [0006] Musculoskeletal system diseases are more common in clinical practice, involving bones, intervertebral discs, nerves, muscles, joints, soft tissues and other diseases. There are also many causes of musculoskeletal pain, such as inflammation, mechanical injury, immune reasons, tumors, etc. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 陈阳生孙桂玉臧云龙刘晓霞王明刚王清亭牛建兴耿立朵刘薇
Owner CP PHARMA QINGDAO CO LTD
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