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
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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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