Method for detecting trans-4-aminocyclohexanol in ambroxol hydrochloride injection
A technology of ambroxol hydrochloride and aminocyclohexanol, which is applied in the detection field of trans-4-aminocyclohexanol, can solve the problems of weak ultraviolet absorption and inability to use ultraviolet detectors, and achieve the maintenance of drug safety and improvement of drug quality. Effect of quality control level, good specificity
Pending Publication Date: 2022-03-04
SHANDONG QIDU PHARMA
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Problems solved by technology
[0006] At present, trans-4-aminocyclohexanol is not included in the standards of ambroxol hydrochloride raw materials and preparations in the pharmacopoeias of various countries. It can be seen from the structure that trans-4-aminocyclohexanol itself has extremely weak ultraviolet absorption, and it is impossible to use high-efficiency Analysis by liquid phase method with UV detector
Method used
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Embodiment 1
[0059] Good exclusive property:
[0060] It is proven, blank solvent, blank excipient, other known impurities to detect anti-4-amino cyclohexanol detection without interference.
Embodiment 2
[0062] Good system applicability:
[0063] Test, systematic applicability test, the number of trans-4-amino cyclohexanol theoretical plates, trailing factors, separation in line with requirements; trans-4-amino cyclohexanol retention time RSD is 0.1% (n = 6 ), Trans-4-amino cyclohexanol peak area RSD is 2.6% (n = 6), which meets the requirements.
[0064] Table 1 Retro-4-amino cyclohexanol system applicability test results
[0065]
[0066]
Embodiment 3
[0068] Good sensitivity:
[0069] The quantification of trans-4-amino cyclohexanol is 0.4436 μg / ml, S / N is 11.16; the detection limit is 0.1331 μg / mL, S / N is 3.38.
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The invention relates to a method for detecting trans-4-aminocyclohexanol in an ambroxol hydrochloride injection, and belongs to the technical field of pharmaceutical analysis. The detection method adopts a gas chromatographic method for detection, and specifically comprises the following steps: 1) preparing a test solution; 2) preparing a reference substance solution; 3) determination; 4) a result calculation formula; and detailed gas chromatograph detection conditions are provided. The gas chromatography adopts a programmed heating mode, and the method can realize effective detection of trans-4-aminocyclohexanol, can quantify the content of trans-4-aminocyclohexanol in ambroxol hydrochloride and an ambroxol hydrochloride injection, effectively monitors the quality of the ambroxol hydrochloride injection, and improves the medication safety.
Description
Technical field [0001] The present invention relates to a method for detecting one kind of the ammonia injection ambroxol hydrochloride trans-4-aminocyclohexanol belongs to the technical field of pharmaceutical analysis. Background technique [0002] Ambroxol suitable for injection with abnormal mucus secretion and adverse expectoration function acute, chronic lung disease; prophylactic treatment of postoperative pulmonary complications; preterm children and newborn babies respiratory distress syndrome (IRDS) treatment. A wide range of clinical value. [0003] Trans-4-aminocyclohexanol as a starting material ambroxol hydrochloride synthetic material, after condensation, reduction, multi-step synthesis reaction of the salt formation, to generate ambroxol. Considering the ambroxol hydrochloride after exposure to light, heat, oxygen may degrade, with the storage time, the content will be trans-4-amino cyclohexanol increases, strict quality control, anti-demand impurities -4-amino-cy...
Claims
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IPC IPC(8): G01N30/02G01N30/04G01N30/06G01N30/12G01N30/86G01N30/68G01N30/14G01N30/88
CPCG01N30/02G01N30/04G01N30/06G01N30/12G01N30/8634G01N30/68G01N30/14G01N30/88G01N2030/047G01N2030/126G01N2030/884
Inventor 王君杰任传杰于黎鑫李福海辛园园张雪马晓红宋彩香谢建卫马莹莹
Owner SHANDONG QIDU PHARMA
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