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Method for determination of related substances of paracetamol and tramadol hydrochloride capsules

A technology of related substances and determination methods, which is applied in the field of determination of related substances of paracetamol tramadol capsules, to achieve the effects of improving detection ability, quality control, and scientific and reasonable methods

Active Publication Date: 2017-03-22
SHANXI GOODDOCTOR PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are relatively few literatures on the determination of related substances of acetaminophen and tramadol

Method used

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  • Method for determination of related substances of paracetamol and tramadol hydrochloride capsules
  • Method for determination of related substances of paracetamol and tramadol hydrochloride capsules
  • Method for determination of related substances of paracetamol and tramadol hydrochloride capsules

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 1 Experimental instruments, materials and reagents

[0029] Sample: Amphenol tramadol capsules (batch numbers: 140601, 140602, 140603), provided by Shanxi Good Doctor Pharmaceutical Co., Ltd.;

[0030] Reference substances: paracetamol (batch number: 100018-200408), tramadol hydrochloride (batch number: 171242-201005), cis-trama hydrochloride (batch number: 171255-201103), p-aminophen (batch number: 100802-201002) , from China National Institute for the Control of Pharmaceutical and Biological Products, China National Institute for Food and Drug Control;

[0031] Reagents: tetrahydrofuran is chromatographically pure, triethylamine, phosphoric acid and potassium dihydrogen phosphate are analytically pure, and water is self-made ultrapure water;

[0032] Instruments: Agilent 1200 high performance liquid chromatography (Agilent), LC-2010CHT high performance liquid chromatography (Shimadzu, Japan), electronic balance Mettler XS-205.

[0033] 2 Experimental part

[0034] ...

experiment example 1

[0048] Experimental Example 1 Determination of Related Substances in Tramadol Capsules and Screening of Chromatographic Conditions

[0049] Basic chromatographic conditions: octylsilane bonded silica gel as filler, 0.005M potassium dihydrogen phosphate (containing 0.1% phosphoric acid and 0.1% triethylamine)-tetrahydrofuran (95:5) as mobile phase, flow rate 1.0ml / min, The column temperature is 35°C.

[0050] (1) Detection wavelength selection

[0051] With reference to the detection wavelength 216nm of related substances in the paracetamol tramadol tablets in the USP United States Pharmacopoeia (36), 215nm was selected as the detection wavelength. Although the solvent peak detected at 215nm wavelength is more obvious, it does not interfere with the detection of related substances, and it is also conducive to the detection of impurities with only terminal ultraviolet absorption. Therefore, the detection wavelength of 215nm is determined to be selected.

[0052] (2) Specificity ...

experiment example 2

[0063] Experimental Example 2 Methodological Investigation of Determination of Related Substances in Tramadol Capsules

[0064] 2.1 Investigation on detection method of cis-tramadol hydrochloride

[0065] ① Linear inspection

[0066] Take an appropriate amount of cis-tramadol hydrochloride reference substance, accurately weigh it, add methanol-water (1:9) to dissolve and make the concentration 11 μg / ml, 5.5 μg / ml, 3.3 μg / ml, 1.1 μg / ml, 0.55 μg / ml, 0.33μg / ml, 0.11μg / ml, 0.055μg / ml and 0.0275μg / ml serial standard curve solution. Precisely measure 10 μl of the linear series of solutions and inject them into the liquid chromatograph respectively, record the chromatogram, take the peak area as the ordinate, and the concentration as the abscissa, and the linear equation obtained by regression is y=14953x-61.488, R 2 =1; the linear range is 0.0275-11.007 μg / ml. The results are shown in Table 1 and Figure 8 .

[0067] Table 1 Linear Data Table

[0068]

[0069]

[0070] ...

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Abstract

The invention discloses a method for determination of related substances of paracetamol and tramadol hydrochloride capsules; a high performance liquid chromatography (HPLC) is adopted, a chromatographic column with octylsilane bonded silica gel as a filler is used, potassium dihydrogen phosphate and tetrahydrofuran are used as a mobile phase, chromatographic conditions are screened and improved, and an HPLC reference substance method is added for inspecting the content of cis-tramadol hydrochloride; the inspecting ability is improved, the limits of cis-ramadol hydrochloride and other related substances are formulated, the quality of the paracetamol and tramadol hydrochloride capsules is effectively controlled, and the safety and effectiveness of the paracetamol and tramadol hydrochloride capsules are ensured.

Description

technical field [0001] The invention relates to the field of drug content determination methods, in particular to a method for determination of related substances in acetaminophen tramadol capsules. Background technique [0002] Tramadol Capsules is a compound preparation composed of acetaminophen and tramadol hydrochloride. It is a new dosage form further developed on the basis of compound tramadol hydrochloride tablets. It is mostly used clinically for moderate to severe acute pain. short-term treatment. Tramadol acetaminophen combines the effects of two single drugs, tramadol hydrochloride and acetaminophen, and gives full play to the characteristics of each single drug. It acts faster than tramadol hydrochloride, and the pain relief time is longer than that of acetaminophen Long, the dosage of the two drugs is reduced, and the combined use has a synergistic effect. [0003] The 2015 edition of "Pharmacopoeia of the People's Republic of China" contains the quality stand...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 耿福昌耿福能
Owner SHANXI GOODDOCTOR PHARMA CO LTD
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