Validation of UV-HPLC method for simultaneous quantification of organic acids in disinfectants for haemodialysis machines

HPLC method was validated for quantification of citric, lactic and malic acids chromatographic separation was performed at 40°C by using mobile phase comprised a mixture (90:10) of potassium phosphate monobasic (50mM) and acetonitrile and pH was adjusted to 2.8 with ortho phosphori A pore size reverse phase column (250mm◊4.6mm) at λ=210 nm using UV with 1.25ml/min flow rate. ICH guidelines were adopted to perform the validation studies that the anal ytical method's characteristics are reliable t hroughout the time during analysis. Validation para meters showed efficiency and adequate linearity with correlation coefficient (r 2 ) 0.9997, 0.9998 and 0.9997 g/ml lactic acid and malic acid respectively. The repeatability a nd intermediate precision (%RSD<2) indicated the method reproducibility. The limits of detection (LOD) 1.93 μ g/ml and the limit of quantification (LOQ) were 6.4 6 μg/ml, 0.34 μg/ml and 0.68 μg/ml for citric acid, lactic acid Recovery ± SD for citric, lactic and malic acids was 98.22±0.24 101.26±0.03 and 97.42±0.03 - 100.5±0.07 respectively for three spikes levels. Organic acids, HPLC, Disinfectants, Haemodialysis