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高效液相色谱法对药物制剂中加替沙星、左氧氟沙星、洛美沙星和培氟沙星等氟喹诺酮类抗生素进行定量测定。

Quantitative determination of gatifloxacin, levofloxacin, lomefloxacin and pefloxacin fluoroquinolonic antibiotics in pharmaceutical preparations by high-performance liquid chromatography.

作者信息

Santoro Maria Inês R M, Kassab Nájla M, Singh Anil K, Kedor-Hackmam Erika R M

机构信息

Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Caixa Postal 66083, CEP 05315-970 São Paulo, Brazil.

出版信息

J Pharm Biomed Anal. 2006 Jan 23;40(1):179-84. doi: 10.1016/j.jpba.2005.06.018. Epub 2005 Aug 10.

Abstract

The objective of this research was to develop and validate analytical methods for quantitative determination of fluoroquinolones of third generation. Simple and rapid chromatographic method was developed and validated for quantitative determination of four quinolone antibiotics in tablets and injection preparations. The fluoroquinolones studied were gatifloxacin (GAT), levofloxacin (LEV), lomefloxacin (LOM) and pefloxacin (PEF). The quinolones were analyzed by using a LiChrospher 100 RP-18 column (5 microm, 125 mm x 4 mm) and a mobile phase constituted of water:acetonitrile (80:20, v/v) with 0.3% of triethylamine and pH adjusted to 3.3 with phosphoric acid. The flow rate was 1.0 mL/min and the analyses were performed using UV detector with wavelengths varying from 279 to 295 nm. The analyses were performed at room temperature (24 +/- 2 degrees C). All fluoroquinolones were separated within 5 min. The calibration curves were linear (r>or=0.9999) over a concentration range from 4.0 to 24.0 microg/mL. The relative standard deviation (R.S.D.) was < 1.0% and average recovery was above 99.54%.

摘要

本研究的目的是开发并验证第三代氟喹诺酮类药物的定量分析方法。开发并验证了一种简单快速的色谱方法,用于定量测定片剂和注射剂中的四种喹诺酮类抗生素。所研究的氟喹诺酮类药物有加替沙星(GAT)、左氧氟沙星(LEV)、洛美沙星(LOM)和培氟沙星(PEF)。使用LiChrospher 100 RP - 18柱(5微米,125毫米×4毫米)和由水:乙腈(80:20,v/v)组成的流动相进行喹诺酮类药物分析,流动相中含有0.3%的三乙胺,并用磷酸将pH值调至3.3。流速为1.0毫升/分钟,使用紫外检测器在279至295纳米的波长范围内进行分析。分析在室温(24±2℃)下进行。所有氟喹诺酮类药物在5分钟内分离。校准曲线在4.0至24.0微克/毫升的浓度范围内呈线性(r≥0.9999)。相对标准偏差(R.S.D.)小于1.0%,平均回收率高于99.54%。

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