| The low-pole drugs, which are insoluble in water even inmethanol, were generally analyzed by normal phase highperformance liquid chromatography (NP-HPLC) and gaschromatography (GC). Compared with RP-HPLC, NP-HPLC ismore tedious, too expensive and more easily influenced byexternal factors. So it is unsuitable for a regular analysis method.GC is generally used for the analysis of the sample that can bevolatilized at the work temperature. So GC can't be used for theanalysis of the drugs with high boiling point or unstable at heat.And the retention time of low-pole drugs may be very long byRP-HPLC with the mobile phase involving water. Organicalkaline drugs were generally analyzed by RP-HPLC with themobile phase involving buffer solution and triethylamine, whichwould shorten the life of column. We analyzed retinol palmitate,ergocalciferol,colecalciferol,vitamin E acetate,phytonadione,aripiprazole,terbinafine hydrochloride,naftifine hydrochlorideby nonaqueous RP-HPLC, and studied the regularity of retention.The results show that nonaqueous RP-HPLC has many goodcharacteristics: the load capacity of column is larger; theretention time is shorter; nonaqueous organic solvent can cutdown the dielectric constant of mobile phase, increase theoryplate number; nonaqueous mobile phase can postpone the life ofcolumn. Therefore, nonaqueous RP-HPLC is suitable for analysisof fat-soluble drugs and organic alkaline drugs.PART 1 Nonaqueous RP-HPLC Determination of Fat-solubleVitamins1 Nonaquaous RP-HPLC Determination of Retinol Palmitate,Colecalciferol and Vitamin E Acetate SimultaneouslyObjective: To establish nonaqueous RP-HPLC to determineretinol palmitate ,colecalciferol and vitamin E acetate inmulti-vitamin injection simultaneously, and study the retentioncharacteristic.Method: The determination was performed on Warters C18column (150×4.6 mm, 5.0 μm) with the mobile phase ofacetonitrile-methanol-dichloromethane(70:20:10),at a flow rateof 1.0 ml/min and the detection wavelength of 265 nm.Results: In the linear range the correlation coefficients wereall 0.999 9.The average recoveries were 99.1%, 100.6%, 99.2%,RSD was in the range of 0.32%0.70%.Conclusion: Nonaqueous RP-HPLC is suitable for theanalysis of fat-soluble vitamins in commercial form, with goodresolution, shorter time, wide linear range and high theory platenumber.2 Nonaqueous RP-HPLC Determination of Retinol Palmitate,Ergocalciferol ,Vitamin E Acetate and PhytonadioneSimultaneouslyObjective: To establish nonaqueous RP-HPLC to determineretinol palmitate ,ergocalciferol ,vitamin E acetate andphytonadione in multi-vitamin injection simultaneously, andstudy the retention characteristic.Method: The determination was performed on Warters C18column (150×4.6 mm, 5.0 μm) with the mobile phase consistingof acetonitrile-methanol (80:20),at a flow rate of 1.0 ml/min andthe detection wavelenth of 265 nm.Results: In the linear range the correlation coefficients were all 0.9999.The average recoveries were 99.9%, 100.3%, 99.6%, 99.7% , RSD was in the range of 0.16%0.96%.Conclusion: Nonaqueous RP-HPLC is suitable for theanalysis of fat-soluble vitamins in preparation, with shorter time,wider linear range and high theory plate number.PART 2 Nonaqueous RP-HPLC Determination of Low-poleOrganic nitrogen Compounds and its Salts1 Nonaqueous RP-HPLC Determination of AripiprazoleObjective: To establish nonaqueous RP-HPLC to determinearipiprazole in material and tablet.Method: The determination was performed on DiamonsilC18 column (250×4.6 mm, 5.0 μm) with the mobile phase ofmethanol-triethylamine (99.9: 0.1),at a flow rate of 1.0 ml/minand the detection wavelength of 257 nm.Results: Aripiprazole was linear in the range of 1.57～405mg/L, r=0.9999.The recoveries of three levels were 100.1%,100.3%,99.8%, RSD <0.52%.Conclusion: The method is quick, with wide linear rangeand high theory plate number. There is not buffer solution andtriethylamine in mobile phase, so can postpone the life of column.So Nonaqueous RP-HPLC can be used for the quick analysis ofaripiprazole in material and tablet.2 Nonaqueous RP-HPLC Determination of TerbinafineHydrochloride and its Related SubstancesObjective: To establish nonaqueous RP-HPLC to determineterbinafine hydrochloride and its related substances in materialand cream.Method: The determination was performed on PhenomenexC18 column (250×4.6 mm, 5.0 μm) with the mobile phase ofmethanol,at a flow rate of 1.0 ml/min and the detectionwavelength of 282 nm.Results: Terbinafine hydrochloride was linear in the rangeof 5.7×10-31.15 mg/ml, r=0.9999.The recoveries of three levelswere 99.5%,99.8%,100.2%, RSD <0. 86 %.Conclusion: The method is quick, with wide linear rangeand high theory plate number. The mobile phase is without buffersolution and triethylamine, so can decrease the damage tostationary phase. So Nonaqueous RP-HPLC is suitable for theanalysis of terbinafine hydrochloride and its related substances inmaterial and cream.3 Nonaqueous RP-HPLC Determination of NaftifineHydrochlorideObjective: To establish nonaqueous RP-HPLC to determinenaftifine hydrochloride.Method: The determination was performed on PhenomenexC18 column (250×4.6 mm, 5.0 μm) with the mobile phase ofmethanol,at a flow rate of 1.0 ml/min and the detectionwavelength of 254 nm.Results: Naftifine hydrochloride was linear in the range of4.12×10-3 4.12×10-2 mg/ml, r=0.9999.The average recoverywas 100.8%,100.2%,99.8%,RSD <0.52 %.Conclusion: The method is quick, with wide linear rangeand high theory plate number. The mobile phase is without buffer...
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