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Method of detecting glucose degradation products in buprenorphine hydrochloride injection

A buprenorphine hydrochloride and detection method technology, applied in the field of medicine, can solve the problems affecting product quality evaluation, inability to separate 5-hydroxymethylfurfural from other degradation products, etc.

Inactive Publication Date: 2016-11-23
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Description
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Problems solved by technology

5-Hydroxymethylfurfural is a very polar small molecular compound, which is eluted very quickly under conventional chromatographic conditions (close to the dead volume time of the chromatographic column); separated from other degradants
If the glucose degradation product is misidentified as an impurity of buprenorphine hydrochloride, it will affect the evaluation of product quality

Method used

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  • Method of detecting glucose degradation products in buprenorphine hydrochloride injection
  • Method of detecting glucose degradation products in buprenorphine hydrochloride injection
  • Method of detecting glucose degradation products in buprenorphine hydrochloride injection

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Experimental program
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Effect test

Embodiment 1

[0019] Chromatographic conditions: ODS chromatographic column is used; the mobile phase A is acetonitrile-potassium dihydrogen phosphate buffer (5.44g potassium dihydrogen phosphate is dissolved in 900ml water, adjusted to pH 4.5 with 5% phosphoric acid, diluted to 1000ml with water), the volume ratio is 10:90, the mobile phase B was acetonitrile, and the gradient elution program was shown in Table 1. The detection wavelength is 284nm, the flow rate is 1.0ml / min, and the column temperature is 30°C.

[0020] Determination method: Take buprenorphine hydrochloride injection and 5% glucose injection to measure according to the above conditions; take another 5-hydroxymethylfurfural reference substance, weigh it accurately, add water to dissolve and dilute to make a solution containing 10 μg per 1ml , as a reference solution.

[0021] The measurement results show that the retention time of 5-hydroxymethylfurfural is about 4.5min, which is much longer than the dead time of the chrom...

Embodiment 2

[0023] According to the detection conditions of "5-hydroxymethylfurfural" under the item of buprenorphine hydrochloride injection in the Chinese Pharmacopoeia 2010 edition.

[0024] Chromatographic conditions: ODS column is used; mobile phase is methanol-acetonitrile-2% ammonium acetate solution-glacial acetic acid (60:10:40:5); flow rate is 1.0ml / min; detection wavelength is 288nm; column temperature is 30°C .

[0025] Determination method: Take buprenorphine hydrochloride injection and 5% glucose injection to measure according to the above conditions; take another 5-hydroxymethylfurfural reference substance, weigh it accurately, add water to dissolve and dilute to make a solution containing 10 μg per 1ml , as a reference solution.

[0026] The measurement results showed that the retention time of 5-hydroxymethylfurfural was about 3 minutes, which was close to the solvent peak, and the separation was not complete, and other degradation products of glucose were not separated,...

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Abstract

The invention relates to a method of detecting glucose degradation products in a buprenorphine hydrochloride injection. The analysis method is mainly used for detecting the glucose degradation products except 5-hydroxymethyl furfural and can effectively separate the chromatographic peaks of the 5-hydroxymethyl furfural, unknown glucose degradation products and buprenorphine in the buprenorphine hydrochloride injection, and especially, completely separate the 5-hydroxymethyl furfural from the unknown glucose degradation products. The method has strong specificity and can control the contents of the 5-hydroxymethyl furfural and the unknown glucose degradation products accurately.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a method for detecting glucose degradation products in injections. Background technique [0002] Buprenorphine hydrochloride is a partial antagonist-agonist of opioid receptors. Clinical studies have shown that buprenorphine hydrochloride has a strong analgesic effect, and its physical dependence is lower than that of morphine and meperidine, while its mental dependence is equivalent to that of morphine, and its analgesic effect is better than that of meperidine. Buprenorphine hydrochloride injection is a sterilized aqueous solution of buprenorphine hydrochloride and glucose. Angina and other visceral pains. [0003] Glucose is unstable in acidic solution and is easily degraded into 5-hydroxymethylfurfural (HMF); 5-hydroxymethylfurfural is decomposed into levulinic acid and acetic acid or forms 5-hydroxymethylfurfural polymer. Recently, it has been reported in the literature tha...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 宋丽明刘亚梅王杏林杨昕
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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