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Method for determining impurities for paracetamol and tramadol hydrochloride preparation

A technology for acetaminophen and tramadol hydrochloride, which is applied in the field of determination of impurities in acetaminophen and tramadol hydrochloride preparations, and can solve problems that do not involve the determination of aminophenol

Active Publication Date: 2009-06-10
SHANGHAI HUA SURNAME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There have been many reports on the HPLC method for the inspection of related substances in these two single preparations, and there are also some studies on the content determination of compound preparations, but there is only one report about the assay method of related substances, "Compound Tramadol Hydrochloride Tablets and Related Substances HPLC Determination", the content of the report mainly focuses on the content determination, but does not involve the determination of p-aminophenol

Method used

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  • Method for determining impurities for paracetamol and tramadol hydrochloride preparation
  • Method for determining impurities for paracetamol and tramadol hydrochloride preparation
  • Method for determining impurities for paracetamol and tramadol hydrochloride preparation

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Effect test

Embodiment 1

[0028] Application of the present invention in the orally disintegrating tablets of acetaminophen tramadol

[0029] Preparation 1

[0030] 325mg / 37.5mg Tramadol Aminophenol Orally Disintegrating Tablets

[0031] components Amount added Acetaminophen 325mg tramadol hydrochloride 37.5mg Acrylic 8mg β-cyclodextrin 110mg

[0032] Ethyl cellulose 15mg aspartame 5mg ethyl maltol 4mg lemon zest 13mg Crospovidone 46mg Sodium dodecyl sulfate 10mg Mannitol 60mg silica 6.1mg Polyvinylpyrrolidone 0.4mg

[0033] Determination method of related substances:

[0034] Take 10 tablets of tramadol orally disintegrating acetaminophen, weigh them accurately, grind them finely, accurately weigh an appropriate amount (approximately equivalent to 37.5 mg of tramadol hydrochloride), put them in a 100ml measuring bottle, add mobile phase A (acetic acid-acetic acid Sodium buffer solutio...

Embodiment 2

[0046] Preparation 2

[0047] 325mg / 37.5mg paracetamol tramadol tablets

[0048] components Amount added Acetaminophen 325mg tramadol hydrochloride 37.5mg Acrylic 15mg β-cyclodextrin 60mg Ethyl cellulose 8mg aspartame 10mg lemon zest 8mg Crospovidone 50mg Sodium carboxymethyl starch 20mg Mannitol 70mg pregelatinized starch 30mg silica 6.0mg Polyvinylpyrrolidone 0.5mg

[0049] Determination method of related substances:

[0050] Take 10 acetaminophen tramadol tablets, accurately weigh them, grind them finely, accurately weigh an appropriate amount (about equivalent to 15 mg of tramadol hydrochloride), put them in a 100ml measuring bottle, add solvent (water-methanol (78:22)) Ultrasound is dissolved and diluted to the scale, shaken up, filtered, and the subsequent filtrate is taken as the test solution of tramadol acetaminophen tablets; 1ml of the test solution of tramadol...

Embodiment 3

[0060] Preparation is the same as embodiment 2

[0061] Determination method of related substances:

[0062] Take 10 paracetamol tramadol tablets, accurately weigh them, grind them finely, accurately weigh an appropriate amount (about 75 mg of tramadol hydrochloride), put them in a 100ml measuring bottle, add solvent (water) to dissolve and dilute to the mark by ultrasonic , shake well, filter, get the continued filtrate as the test solution of tramadol acetaminophen tablets; accurately measure 1ml of the test solution of tramadol acetaminophen tablets, put in a 100ml measuring bottle, add solvent (water) to dilute to Scale, as the reference solution (1); take another appropriate amount of para-aminophenol reference substance, weigh it accurately, add solvent (water) to make a solution containing 6.5 μg per 1 ml, and use it as the reference solution (2). According to high-performance liquid chromatography, use BDSHYPERSIL C18 chromatographic column; use acetic acid-sodium ace...

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Abstract

The invention discloses a method to measure contaminant of acet amidogen phenol and tramadol hydrochloride preparation. Using this invention, it can be simple, rapid and accurate detect pair amidogen phenol content in the preparation, the detection error of only 0.4%, while it can detect others unknown impurity gross, the invention will be able to meet the needs of the parties concerned.

Description

technical field [0001] The invention relates to a method for detecting impurities in a compound preparation of acetaminophen and tramadol hydrochloride, in particular to a method for detecting related substances in a compound preparation containing acetaminophen and tramadol hydrochloride by using an HPLC method. Background technique [0002] The compound preparation of tramadol hydrochloride and paracetamol was approved by the FDA in the United States in August 2001 for the short-term treatment of acute pain (5d). Clinical studies have shown that, compared with a single component, the compound preparation is more effective in treating pain, and has a quick onset and a long duration of action. [0003] There have been many reports on the HPLC method for the inspection of related substances in these two single preparations, and there are also some studies on the content determination of compound preparations, but there is only one report about the assay method of related subs...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/60G01N30/34
Inventor 张冬梅余伟民
Owner SHANGHAI HUA SURNAME PHARMA
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