Shabir Ghulam A
Fleet Laboratories, 94 Rickmansworth Road, Watford, Herts WD18 7JJ, UK.
J Pharm Biomed Anal. 2004 Jan 27;34(1):207-13. doi: 10.1016/j.japna.2003.07.006.
This paper describes a reversed-phase high performance liquid chromatographic (RP-HPLC) assay method for the determination of combined p-hydroxy benzoic acid (ethylparaben (EP), methylparaben (MP) and propylparaben (PP)) preservatives in a liquid pharmaceutical formulation. The chromatographic separation was achieved with potassium phosphate buffer (pH 7.05)-methanol (47.5:52.5, v/v) as mobile phase, a Spherisorb C(18) column (250 mm x 4.6mm) and UV detection at 254 nm. The analysis time was <8 min. The method was validated with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The calibration curves showed good linearity over the concentration range of 2-140 microg/ml. The correlation coefficient were >0.9999 in each case. The relative standard deviation (R.S.D.) values for intra- and inter-day precision studies were <1%. The procedure describe here is simple, selective and is suitable for routine quality control analysis and stability tests.
本文描述了一种反相高效液相色谱（RP-HPLC）分析方法，用于测定液体制剂中对羟基苯甲酸（对羟基苯甲酸乙酯（EP）、对羟基苯甲酸甲酯（MP）和对羟基苯甲酸丙酯（PP））组合防腐剂的含量。以磷酸钾缓冲液（pH 7.05）-甲醇（47.5:52.5，v/v）为流动相，使用Spherisorb C(18)柱（250 mm×4.6mm），在254 nm波长处进行紫外检测，实现了色谱分离。分析时间<8分钟。该方法在线性、精密度、准确度、选择性、特异性和耐用性方面进行了验证。校准曲线在2-140μg/ml的浓度范围内显示出良好的线性。每种情况下相关系数均>0.9999。日内和日间精密度研究的相对标准偏差（R.S.D.）值<1%。本文所述方法简单、具有选择性，适用于常规质量控制分析和稳定性试验。
