用于测定头孢妥仑匹酯的稳定性指示液相色谱-紫外法的开发与验证
Development and validation of the stability-indicating LC-UV method for the determination of Cefditoren pivoxil.
作者信息
Annapurna M Mathrusri, Goutam S V S, Anusha S, Srinivas L
机构信息
Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam 530045, India.
出版信息
J Pharm Anal. 2012 Dec;2(6):466-469. doi: 10.1016/j.jpha.2012.06.003. Epub 2012 Jun 27.
An isocratic RP-HPLC method was developed for the determination of Cefditoren pivoxil in pharmaceutical formulations using a C-18 column with water-acetonitrile (50:50, v/v) as mobile phase and flow rate 1.2 mL/min (UV detection at 218 nm). Linearity was observed in the concentration range 1.0-250 μg/mL (=0.999) with regression equation =24194+10749. The forced degradation studies were performed by using HCl, NaOH, and HO, and thermal and UV radiation. Cefditoren pivoxil is more sensitive towards oxidation and alkaline conditions and resistant towards acidic and photolytic degradations. The method was validated as per ICH guidelines.
建立了一种等度反相高效液相色谱法，用于测定药物制剂中的头孢妥仑匹伏酯，采用C-18柱，以水-乙腈（50:50，v/v）为流动相，流速为1.2 mL/min（在218 nm处进行紫外检测）。在1.0-250 μg/mL的浓度范围内观察到线性关系（=0.999），回归方程为=24194+10749。通过使用盐酸、氢氧化钠和过氧化氢以及热和紫外线辐射进行强制降解研究。头孢妥仑匹伏酯对氧化和碱性条件更敏感，对酸性和光解降解具有抗性。该方法按照国际人用药品注册技术协调会（ICH）指南进行了验证。
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