使用高效液相色谱法（HPLC）和超高效液相色谱法（UPLC）对阿立哌唑进行色谱测定：一项比较验证研究。

Thakkar R S, Saravaia H T, Ambasana M A, Kaila H O, Shah A K

National Facility for Drug Discovery through NCE's Development and Instrumentation Support to SMPE's, Department of Chemistry, Saurashtra University, Rajkot-360 005, India.

Indian J Pharm Sci. 2011 Jul;73(4):439-43. doi: 10.4103/0250-474X.95638.

A simple, precise, and accurate isocratic reversed-phase (RP) stability-indicating HPLC assay method was developed and validated for determination of Aripiprazole in bulk and solid pharmaceutical dosage form. A reversed-phase C8 (250×4.0 mm, 5 μm particle size) column for HPLC and C8 (50×2.1mm, 1.7 μm particle size) for UPLC method in isocratic mode was used. The mobile phase consists of acetonitrile: 20 mM ammonium acetate (90:10, v/v), flow rate was set at 1.0 ml/min and 0.250 ml/min for HPLC and UPLC, respectively and the detection was performed for both methods were at 240 nm. Further the validation of both developed method was performed and subsequently compared to prove its better applicability.

开发并验证了一种简单、精确且准确的等度反相（RP）稳定性指示高效液相色谱（HPLC）测定法，用于测定原料药和固体药物剂型中的阿立哌唑。采用等度模式下的反相C8（250×4.0 mm，粒径5μm）HPLC柱和C8（50×2.1mm，粒径1.7μm）超高效液相色谱（UPLC）柱。流动相由乙腈：20 mM醋酸铵（90:10，v/v）组成，HPLC和UPLC的流速分别设定为1.0 ml/min和0.250 ml/min，两种方法的检测波长均为240 nm。进一步对两种开发方法进行了验证，并随后进行比较以证明其更好的适用性。