1Department of Chemistry, Thanjavur – Pin- 613403. Tamilnadu, India.
2Prist University, East Campus, Thanjavur – Pin- 613403. Tamilnadu, India.
A sensitive, simple, specific, precise, accurate and rugged method for determination of enantiomeric impurity of l-Ephedrine Sulfate (l-EPS) 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. The method was validated for the quantification of d-Ephedrine enantiomeric impurity (d-EPS) in the bulk drug, 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 d-EPS. Precision of the method, the relative standard deviation was 0.99%.limit of detection (LOD) and limit of quantification (LOQ) of the method for d-EPS were 0.04% and 0.16% respectively. Average recovery of the d-EPS was 107.48%. This method was employed in determining enantiomeric impurity of bulk drug l-EPS.
HPLC, enantiomeric impurity, l-Ephedrine Sulfate (l-EPS) and d-Ephedrine Sulfate (d-EPS)
