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HPLC method for the separation and determination of two drugs and antibacterial agents in naftifine ketoconazole cream
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A technology for naftifine ketoconazole cream and bacteriostatic agent, which is applied in the field of analytical chemistry and achieves the effects of good repeatability and accurate and reliable inspection results
Active Publication Date: 2020-08-11
CHONGQING HUAPONT PHARMA
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So far, there is no published method report that can effectively separate and quantify the two drugs and bacteriostatic agents in naftifine ketoconazole cream
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Embodiment 1
[0052] The method of two kinds of medicines and antibacterial agent content in the embodiment 1 separation and determination naftifine ketoconazole emulsifiable cream
[0065] Sample preparation: Take 0.5g of this product, weigh it accurately, put it in a 50ml measuring bottle, add 30ml of 80% methanol, heat it in a water bath at 60°C, shake it to melt and disperse the paste, continue to extract for 5 minutes, take it out, and put it on ice Cool in a water bath for more t...
Embodiment 2
[0066] Example 2 sample detection result
[0067] According to the method of Example 1, the content of multiple batches of naftifine ketoconazole cream is detected.
[0068] Table 2 Naftifine ketoconazole cream content detection result
[0070] Embodiment 3 methodological verification Separation and determination of the content of two kinds of drugs in naftifine ketoconazole cream
[0071] 1. Blank matrix interference test
[0072] Get each 0.5g of naftifine ketoconazole emulsifiable paste and blank base, after processing and dissolving according to the above-mentioned content method, sample injection 20 μ l, and record chromatogram ( figure 1 , figure 2 ).
[0073] Test results: The blank matrix does not interfere with the detection of the two drugs and antibacterial agents.
[0075] Precisely weigh about 100 mg of naftifine hydrochloride reference substance, about 25 mg of ketoconazole reference substance, and 20 mg of potassium sorbate reference substance, put them in a 100ml volumetric flask, add 80% methanol to dissolve and dilute to the mark, as a stock solution, and accurately measure Each 3.0, 4.0, 5.0, 6.0, 7.0ml of the stock solution was placed in a 50ml measuring...
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Abstract
The invention belongs to the field of analytical chemistry and specifically relates to a method for separating and determining two drugs and a bacteriostatic agent in Naftifine-ketoconazole cream withan HPLC (high performance liquid chromatography). In a chromatographic column adopted in the method, octadecyl silane bonded silica gel is taken as a filler, gradient elution is performed by adoptinga mobile phase A and a mobile phase B, and detection is performed by a detector; the two drugs are Naftifine hydrochloride and ketoconazole, and the bacteriostatic agent is potassium sorbate; the mobile phase A is an aqueous solution of an ion-pairing agent, and the mobile phase B is an organic solvent. According to the method, the contents of the two drugs and the bacteriostatic agent in the Naftifine-ketoconazole cream are separated and determined simultaneously; the method is good in repeatability, the determination is not interfered by the solvent in detection, and the two drugs and the bacteriostatic agent in the Naftifine-ketoconazole cream and relevant substances thereof can be effectively separated; the degree of separation is greater than 2.0, and a detection result is accurate and reliable. Therefore, the method has an important meaning for quality control of the Naftifine-ketoconazole cream.
Description
technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring two kinds of medicines and a bacteriostatic agent in naftifine ketoconazole cream by HPLC. Background technique [0002] Naftifine and ketoconazole cream is a compound preparation for treating fungal skin diseases. It contains naftifine hydrochloride and ketoconazole. It is a new compound preparation composed of 0.1% naftifine hydrochloride and 0.25% ketoconazole. For tinea pedis, tinea corporis, tinea capitis, skin candidiasis, etc. [0003] Both naftifine hydrochloride and ketoconazole can inhibit the synthesis of ergosterol in fungal cell membranes, destroy the membrane structure and inhibit the growth of fungal cells. However, the mechanisms by which the two affect ergosterol synthesis are different: ketoconazole acts on the C-14 demethylase of lanosteroids, inhibiting the conversion of lanosteroids to 14-desmethyl lanoste...
Claims
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