A kind of detection method of additive in sufentanil medicine
A detection method and drug technology, applied in the field of sufentanil purity, can solve the problems of low recovery rate, secondary pollution, large consumption of organic solvents, etc., and achieve the effect of low cost
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Embodiment 1
[0067] A detection method for additives in sufentanil medicine, comprising the following steps:
[0068] (1) Sample processing:
[0069] S1. after 75mg of sufentanil citrate is dissolved in 900mL of water, the pH is adjusted to 3.7 with citric acid solution, and water is added to 1000mL to obtain the sample mother liquor;
[0070] S2. Take 10 mL of the sample mother liquor in an analysis bottle, add 10 mL of an organic solvent for extraction, separate the organic phase, add anhydrous magnesium sulfate for dehydration, and then test;
[0071] (2) Prepare standard solution; prepare 5 gradient standard series solutions of dibutyl phthalate; the concentrations are 20, 40, 60, 80, 100 μg / L;
[0072] (3) Carry out GC-MS test. The chromatographic conditions of GC-MS are: column is HP-5MS; specification: 30m*0.25mm*0.25μm; carrier gas is high-purity helium, purity ≥99.999%; inlet temperature The injection volume is 1 μL; the injection mode is splitless; the transfer line temperature...
Embodiment 2
[0077] A detection method for additives in sufentanil medicine, comprising the following steps:
[0078] (1) Sample processing:
[0079] S1. after dissolving 75mg of sufentanil citrate in 900mL of water, adjust the pH to 4.2 with citric acid solution, add water to 1000mL to obtain the sample mother liquor;
[0080] S2. Take 10 mL of the sample mother liquor in an analysis bottle, add 10 mL of an organic solvent for extraction, separate the organic phase, add anhydrous magnesium sulfate for dehydration, and then test;
[0081] (2) Prepare standard solution; prepare 5 gradient standard series solutions of dibutyl phthalate; the concentrations are 20, 40, 60, 80, 100 μg / L;
[0082] (3) Carry out GC-MS test. The chromatographic conditions of GC-MS are: column is HP-5MS; specification: 30m*0.25mm*0.25μm; carrier gas is high-purity helium, purity ≥99.999%; inlet temperature The injection volume is 1 μL; the injection mode is splitless; the transfer line temperature is 300°C; the c...
Embodiment 3
[0087] A detection method for additives in sufentanil medicine, comprising the following steps:
[0088] (1) Sample processing:
[0089] S1. after 75mg of sufentanil citrate is dissolved in 900mL of water, the pH is adjusted to 4.0 with citric acid solution, and water is added to 1000mL to obtain the sample mother liquor;
[0090] S2. Take 10 mL of the sample mother liquor in an analysis bottle, add 10 mL of an organic solvent for extraction, separate the organic phase, add anhydrous magnesium sulfate for dehydration, and then test;
[0091] (2) Prepare standard solution; prepare 5 gradient standard series solutions of dibutyl phthalate; the concentrations are 20, 40, 60, 80, 100 μg / L;
[0092] (3) Carry out GC-MS test. The chromatographic conditions of GC-MS are: column is HP-5MS; specification: 30m*0.25mm*0.25μm; carrier gas is high-purity helium, purity ≥99.999%; inlet temperature The injection volume is 1 μL; the injection mode is splitless; the transfer line temperature...
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