Zaxariou M, Panderi I
Division of Pharmaceutical Chemistry, School of Pharmacy, University of Athens, Panepistimiopolis, Zografou 157 71, Athens, Greece.
J Pharm Biomed Anal. 2004 Apr 1;35(1):41-50. doi: 10.1016/j.jpba.2003.12.014.
A stability indicating, reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of buspirone (Bsp) in pharmaceutical dosage forms. The use of a semi-micro XTerra MS C18 (150 mm x 3.0 mm i.d., 5 microm particle size) analytical column, results in substantial reduction in solvent consumption and increased sensitivity. The mobile phase consisted of a mixture of 0.010 M ammonium acetate (pH 4.0) and methanol (55:45, v/v), pumped at a flow rate 0.30 ml min-1. The UV detector was operated at 245 nm. The retention times for lidocaine (Ldc), which was used as internal standard, and buspirone were 4.57 and 7.72 min, respectively. The calibration graph was ranged from 1.00 to 5.00 microg ml-1, while detection and quantitation limits were found to be 0.22 and 0.67 microg ml-1, respectively. The intra- and inter-day relative standard deviation (% R.S.D.) values were less than 1.94%, while the relative percentage error (% Er) was less than 4.0% (n = 5). The method was applied to the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.
建立并验证了一种用于测定药物剂型中丁螺环酮（Bsp）的稳定性指示反相高效液相色谱法。使用半微量XTerra MS C18（150 mm×3.0 mm内径，5微米粒径）分析柱，可大幅减少溶剂消耗并提高灵敏度。流动相由0.010 M醋酸铵（pH 4.0）和甲醇（55:45，v/v）的混合物组成，以0.30 ml min-1的流速泵送。紫外检测器在245 nm下运行。用作内标的利多卡因（Ldc）和丁螺环酮的保留时间分别为4.57和7.72分钟。校准曲线范围为1.00至5.00 microg ml-1，而检测限和定量限分别为0.22和0.67 microg ml-1。日内和日间相对标准偏差（% R.S.D.）值小于1.94%，而相对百分误差（% Er）小于4.0%（n = 5）。该方法应用于市售片剂的质量控制和含量均匀度测试，证明适用于快速可靠的质量控制。
