Standard solutions
Dissolve
USP Antazoline Phosphate RSin methanol,and mix to obtain a solution having a known concentration of 0.10mg per mL.Quantitatively dilute with methanol to obtain 5
Standard solutionshaving the following compositions:
Standard preparation |
Dilution |
Concentration (µg RSper mL) |
Percentage (%,for comparison with test specimen) |
| A |
(1in 2) |
50 |
0.5 |
| B |
(2in 5) |
40 |
0.4 |
| C |
(3in 10) |
30 |
0.3 |
| D |
(1in 5) |
20 |
0.2 |
| E |
(1in 10) |
10 |
0.1 |
Procedure
Apply separately 10µLof the
Test solution,10µLof the
Identification solution,and 10µLof each
Standard solutionto a suitable thin-layer chromatographic plate (see
Chromatography á621ñ),coated with a 0.25-mm layer of chromatographic silica gel mixture.Position the plate in a chromatographic chamber,and develop the chromatograms in a solvent system consisting of a mixture of ethyl acetate,methanol,and diethylamine (17:2:1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Examine the plate under short-wavelength UVlight,and compare the intensities of any secondary spots observed in the chromatogram of the
Test solutionwith those of the principal spots in the chromatograms of the
Standard solutions.
[NOTEDisregard any spots observed at the origins of the chromatograms.
]No secondary spot from the chromatogram of the
Test solutionis larger or more intense than the principal spot obtained from
Standard solution A(0.5%),and the sum of the intensities of all secondary spots obtained from the
Test solutioncorresponds to not more than 1.0%.