A method for checking related substances of tacalcitol ointment

A tacalcitol and inspection method technology, applied in the field of inspection of related substances in tacalcitol ointment, can solve problems such as complex research on tacalcitol ointment, achieve great positive effect and practical application value, and reliable impurity spectrum The effect of strong reference and method specificity

Active Publication Date: 2021-03-30
NANJING HERON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, the analysis methods of tacalcitol ointment mainly rely on sophisticated instruments and complicated research

Method used

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  • A method for checking related substances of tacalcitol ointment
  • A method for checking related substances of tacalcitol ointment
  • A method for checking related substances of tacalcitol ointment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: The high-performance liquid chromatography analysis method of the related substances of the tacalcitol ointment whose specification is 2 μ g / g operates in the dark; take about 1 g of this product (equivalent to 2 μ g of tacalcitol), and put it in a 25 ml headspace bottle , add 5ml of n-hexane, seal, vortex for 5min to dissolve completely, then add 5ml of methanol, vortex for another 5min, let stand to separate layers, discard the upper cloudy solution, and rotate the lower layer at 25°C to dryness, add After 1ml of 80% methanol is dissolved, filter it with a 0.22μm microporous membrane, and the filtrate is used as the test solution; take 0.1ml of the test solution, put it in a 10ml brown measuring bottle, add methanol to dilute to the mark, shake well, and use it as a solution ①, take another 4ml, put it in a 10ml brown measuring bottle, add methanol to dilute to the mark, shake well, and use it as a system suitability solution; measure it according to high...

Embodiment 2

[0052] Embodiment 2 adopts the inspection method of embodiment 1, obtains the related substance (specification 2 μ g / g) of the inventor's self-made tacalcitol ointment

[0053] batch number 20170602 20170603 20170604 Impurity PY1 not detected not detected not detected Maximum other unknown simple heterogeneity (%) not detected not detected not detected Total Miscellaneous (%) not detected not detected not detected

Embodiment 3

[0054] Embodiment 3 comparative example, namely the high performance liquid chromatography analysis method of the related substance of the tacalcitol ointment that specification is 20 μ g / g

[0055] In this example, implementation is carried out with reference to the inspection method for related substances of 20 μg / g tacalcitol ointment in the Japanese Pharmacopoeia.

[0056] Avoid light; take about 1g of this product (equivalent to 20μg of tacalcitol), put it in a 25ml headspace bottle, add 5ml of n-hexane, seal it, vortex for 5min to dissolve it completely, then add 5ml of methanol, and vortex again After standing for 5 minutes, the upper turbid solution was discarded, and the lower layer was rotary evaporated to dryness at 25°C, dissolved in 1ml of methanol, filtered with a 0.22μm microporous membrane, and the filtrate was used as the test solution; Put 0.1ml of product solution in a 10ml brown measuring bottle, add methanol to dilute to the mark, shake well, and use it as...

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PUM

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Abstract

The invention discloses a high performance liquid chromatography method for tacalcitol ointment related substances. Octadecylsilane bonded silica is used as a filler, an acetonitrile-water mixed solution is used as a mobile phase, and a sample solution and a control solution are obtained in a vortex-extraction-concentration manner, so the detection of an extremely low dose of a drug in the above ointment and related substances thereof is greatly ensured, and the solvent system for dissolving and concentrating to form dry residues is optimized, thereby the shape of peaks is sharp, and the reproducibility is good. The method can be used to simultaneously analyze all known impurities in the tacalcitol ointment , and allows the content of each known impurity to be effectively controlled by a main component self-contrasted technology with a correction factor, the resolution among all impurity peaks and the resolution between a main peak and the adjacent impurity peak are respectively greater than 1.5, and the peak purities of the main peak and all the impurity peaks are respectively more than 1.0. The method is a simple and reliable analysis method for the quality control of the tacalcitol ointment.

Description

technical field [0001] The invention belongs to a method for checking related substances of pharmaceutical preparations, in particular to a method for checking related substances of low-concentration tacalcitol ointment. Background technique [0002] Psoriasis, also known as psoriasis, is a chronic inflammatory skin disease with a long duration of illness and is prone to recurrence. Some cases are almost unhealed throughout life; Affected; Clinically, symptoms such as erythema and scales are often present, and the whole body can be affected, especially the scalp and extremities. It is easy to aggravate in winter; currently, the external drugs for the treatment of psoriasis mainly include vitamin D derivatives and corticosteroids Corticosteroids, retinoic acids, anthralin, keratin exfoliants, etc.; corticosteroids are steroids produced by the adrenal cortex, mostly hormones, such as glucocorticoids and mineralocorticosteroids; in the treatment of psoriasis, Combination thera...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/08G01N30/14G01N30/74G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/08G01N30/14G01N30/34G01N30/74G01N30/8634G01N2030/067G01N2030/146
Inventor 李聚江徐丽闵涛石若鹏袁士发柏丹丹王继芳
Owner NANJING HERON PHARM CO LTD
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