Standard preparations
Dissolve
USP Triprolidine Hydrochloride RSin chloroform,and mix to obtain a solution having a known concentration of 1.0mg per mL.Dilute quantitatively with chloroform to obtain four diluted
Standard preparations(
A,
B,
C,and
D)having the following compositions:
| Standard preparation |
Dilution |
Concentration (µg RSper mL) |
Percentage (%, for comparison with test specimen) |
| A |
(1in 5) |
200 |
2.0 |
| B |
(15in 100) |
150 |
1.5 |
| C |
(1in 10) |
100 |
1.0 |
| D |
(5in 100) |
50 |
0.5 |
Procedure
Apply separately 5µLof the
Test preparationand 5µLof each of the eight diluted
Standard to 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,protected from light,in a solvent system consisting of a mixture of chloroform and diethylamine (95:5)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 long-and short-wavelength UVlight.Compare the intensities of any secondary spots observed in the chromatogram of the
Test preparationwith those of the principal spots in the chromatograms of the
Standard preparations:the intensity of the
Z-isomer triprolidine hydrochloride spot (
RFvalue about 1.2relative to the
RFvalue for triprolidine hydrochloride)obtained from the
Test preparationcorresponds to not more than 2.0%,and the sum of the intensities of all secondary spots obtained from the
Test preparationcorresponds to not more than 3.0%.