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Method for simultaneous determination of chlorhexidine gluconate content and parachloroaniline content
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A technology of chlorhexidine gluconate and p-chloroaniline, which is applied in the field of drug detection, and can solve problems such as cumbersome operation, low accuracy, and no inspection
Active Publication Date: 2019-08-02
GUANGDONG SHUNFENG PHARMA
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The quality standard of this product is based on WS-10001-(HD-0153)-2002. After extraction, it is detected by ultraviolet light. This method is cumbersome to operate and the accuracy is not strong.
There was also no testing for related substances (e.g. the main impurity p-chloroaniline)
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Embodiment 1
[0051]Present embodiment provides a kind of method of measuring chlorhexidine gluconate and p-chloroaniline content simultaneously, it comprises the following steps:
[0052] S1, preparation of reference substance solution
[0053] Take appropriate amount of chlorhexidine acetate reference substance and p-chloroaniline reference substance respectively, add diluent to dissolve, respectively as chlorhexidine acetate reference substance solution and chloroaniline reference substance solution, according to containing about 0.1mg of chlorhexidine gluconate in every 1ml , 0.25 μg of p-chloroaniline were mixed to form a mixed reference solution.
[0055] Accurately weigh the sample, put the sample in a measuring bottle, add diluent, heat in a water bath at 80°C, shake to dissolve the sample, let it cool, dilute to the mark with diluent, shake well, and cool in an ice bath After more than 2 hours, take it out and filter it, and let the filtra...
Embodiment 2-5
[0067] Embodiments 2-5 are basically the same as Embodiment 1, except that the elution parameters are different.
[0068] Please refer to Table 4 for the elution parameters of Example 2:
[0070] time (min) Mobile phase A (wt%) Mobile phase B (wt%) gradient curve 0 75 25 linear 20 45 55 linear 25 35 65 linear 35 35 65 linear 37 75 25 linear 45 75 25 linear
[0071] The elution parameter of embodiment 3 please refer to table 5:
[0073] time (min) Mobile phase A (wt%) Mobile phase B (wt%) gradient curve 0 78 22 linear 20 48 52 linear 25 38 62 linear 35 38 62 linear 37 78 22 linear 45 78 22 linear
[0074] The elution parameter of embodiment 4 please refer to table 6:
[0082] Embodiment 6-7 is substantially the same as embodiment 1, and the difference is that the amount of chlorhexidine gluconate and p-chloroaniline contained in the mixed reference substance solution is different:
[0083] In embodiment 6, every 1ml mixed reference substance solution contains chlorhexidine gluconate 0.07mg and p-chloroaniline 0.225 μ g.
[0084] In embodiment 7, contain chlorhexidine gluconate 0.12mg and p-chloroaniline 0.275 μ g in every 1ml mixed reference substance solution.
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Abstract
The invention relates to the field of drug detection and provides a method for simultaneous determination of chlorhexidine gluconate content and parachloroaniline content. The method comprises the steps that a high-performance liquid chromatographic method is used to determine a mixed reference substance solution and a test substance solution, wherein chromatographic conditions include that lineargradient elution is performed on the mixed reference substance solution and the test substance solution respectively by using an ammonium dihydrogen phosphate solution as a mobile phase A and using methanol as a mobile phase B, and the volume of the ammonium dihydrogen phosphate solution is controlled in the linear gradientelution process, so that the percent of the volume of the mobile phase Ain the total quantity of the mobile phases is lowered from 75%-85% to 35%-45% and then is raised to 75%-85%; and the mixed reference substance solution is prepared by mixing a chlorhexidine acetate reference substance and a parachloroaniline reference substance. By the adoption of the high-performance liquid chromatographic method, simultaneous and accurate determination of the chlorhexidine gluconate content and the parachloroaniline content is realized through a specific mobile phase composition and a linear gradientelution program.
Description
technical field [0001] The invention relates to the field of drug detection, in particular to a method for simultaneously determining the contents of chlorhexidine gluconate and p-chloroaniline. Background technique [0002] Chlorhexidine gluconate ointment is an over-the-counter drug for dermatology. The main ingredient of this product is chlorhexidine gluconate, and its main impurity is p-chloroaniline. Chlorhexidine is a cationic surface-active preservative with broad-spectrum antibacterial activity. Its mechanism of action is to change the permeability of the bacterial cell membrane. It is used for mild and small area burns, scalds, and trauma infections, and can also be used for people with eczema, acne, and athlete's foot. The quality standard of this product is based on WS-10001-(HD-0153)-2002, and after extraction, it is detected by ultraviolet light. This method is cumbersome to operate and the accuracy is not strong. There were also no tests for related substan...
Claims
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