Standard preparations
Dissolve
USP Loxapine Succinate RSin methanol and mix to obtain
Standard preparation Ahaving a known concentration of 0.5mg per mL.Dilute portions of
Standard preparation Aquantitatively with methanol to obtain
Standard preparation Band
Standard preparation Chaving known concentrations of 0.25mg per mLand 0.1mg per mL,respectively.
Procedure
Separately apply 5µLof the
Test preparationand each of the three
Standard preparationsto a suitable high performance thin-layer chromatographic plate (see
Chromatography á621ñ)coated with a 0.10-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of ethyl acetate,methanol,and ammonium hydroxide (9:1:0.1)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,air-dry,examine the plate under short-wavelength UVlight,and 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:no secondary spot from the chromatogram of the
Test preparationis larger or more intense than the principal spot obtained from
Standard preparation A(1.0%),and the sum of the intensities of the secondary spots obtained from the
Test preparationcorresponds to not more than 2.0%.