A sensitive, simple, specific, precise, accurate and rugged method for determination of enantiomeric impurity of d-Pseudoephedrine Sulfate (d-PES) a drugs substance has been developed. The separation of isomer is by Diacel, Chiralpak AD-H 250mm X 4.6 mm with 5μ particle size[6]. Column was maintained at 25°C. The UV/Vis detector was operated at 254 nm. Flow rate of the mobile phase was 2.0 ml/min. The method offers excellent separation of two enentiomers with resolution (R) is not less than 2 and tailing factor not more than 3.0. The method was validated for the quantification of l-Pseudoephedrine enantiomer impurity (l-PES) in the bulk drugs, was performed according to the International Conference on Harmonization (ICH) guidelines [1–4]. Calibration curves showed excellent linearity over the concentration range 0.02 to 0.1 mg/ml (0.4% to 2.0%) for l-PES. Precision of the method the relative standard deviation was 0.99%.limit of detection (LOD) and limit of quantification (LOQ) of the method for l-PES were 0.04% and 0.16% respectively. Average recovery of the l-PES was 107.48%. This method was employed in determining enantiomeric impurity of bulk drug d-PES.
HPLC, enantiomer, enantiomeric impurity, d-Pseudoephedrine Sulfate(d-PES) and l-Pseudoephedrine Sulfate(l-PES)
