Determination of combined p-hydroxy benzoic acid preservatives in a liquid pharmaceutical formulation by HPLC.
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.
Shabir
Ghulam A
GA
Fleet Laboratories, 94 Rickmansworth Road, Watford, Herts WD18 7JJ, UK. ghulam.shabir@abbott.com
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D010226:Parabens / Q000032:analysis* / Q000737:chemistry; D019999:Pharmaceutical Solutions / Q000032:analysis / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000032:analysis* / Q000737:chemistry
D010226:Parabens; D019999:Pharmaceutical Solutions; D011310:Preservatives, Pharmaceutical; C038193:4-hydroxybenzoic acid