Method for detecting Tadalafei and derivative thereof
A technology for tadalafil and its derivatives, which is applied in the field of detection of tadalafil and its derivatives, can solve the problems of lack of inspection equipment, difficulty in screening, and inability to identify new derivatives, and achieve strong specificity, sensitive response, The effect of high accuracy
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Embodiment 1
[0021] Embodiment 1, the method for detecting tadalafil and its derivatives
[0022] The specific operations of the method for detecting tadalafil and derivatives thereof of the present invention are as follows:
[0023] 1. Sampling volume
[0024] For different types of samples to be tested, the recommended sampling volume is shown in Table 1 below.
[0025] Table 1 Recommended sampling table
[0026] dosage form
Sampling volume
tablet
1
Contents of 1 capsule
honey pill
1 / 4 pill
single dose oral solution
1 / 2 stick
other solid
0.1-0.2g
[0027] 2. Preparation of the test article
[0028] Preparation of solid test sample Add 5-10ml chloroform to the finely ground or chopped sample, grind to dissolve, filter with filter paper moistened with chloroform in advance, put the filtrate in a white porcelain evaporating dish, evaporate to dryness in a water bath at 80°C or use a hair dryer Blow d...
Embodiment 2
[0038] Embodiment 2, the accuracy test that the inventive method detects tadalafil
[0039] Commercially available 39 batches of samples are detected by the method of the present invention, meanwhile, according to the State Drug and Food Administration Drug Inspection Supplementary Inspection Method and Inspection Item Approval Document (2006009, announced on March 14, 2006), HPLC-MS-MS Methods Check tadalafil, sildenafil citrate, vardenafil hydrochloride, the results are shown in Table 3.
[0040] Table 3: Test results of multiple batches of samples
[0041] product name
Sampling volume
Color rendering result
mass spectrometry results
sample 1
Contents of 1 capsule
blue-purple
tadalafil
sample 2
1 pill
yellowish brown
Does not contain *
sample 3
pill
1 pill
yellowish brown
Does not contain *
Sample 4
piece
1 piece finely powdered
yello...
Embodiment 3
[0046] Embodiment 3, the method of the present invention detects tadalafil derivatives
[0047] The method of the present invention can not only detect tadalafil, but also detect tadalafil derivatives, and its derivatives mainly contain methyl groups on N-heterocycles surrounded by amino groups (-NH 2 ) is substituted, see formula II (aminotadalafil); and the methyl group on the N-containing heterocycle is replaced by ethyl (-CH 2 CH 3 ), hydroxymethyl (-CH 2 OH) substituted derivatives. The process of detecting tadalafil derivatives is the same as that of tadalafil, and the judgment of positive results is also the same.
[0048] (Formula II)
[0049] For the detection of capsule samples containing tadalafil derivatives with the structure of formula II by HPLC-MS-MS method, the content of 1 capsule was taken for detection, and the color development result was blue-purple, which was a positive result.
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Abstract
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