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 excess d-threo-Ritalinic acid (d-TRA) a drug intermediate used to manufacture Methylphenidate and Dexmethylphenidate available in the market to treat Attention Deficient Hyperactivity Disorder (ADHD) has been developed. The separation of entiomer is by Chiral AGP, 5 μm, 150 mm x 4.0mm [6]. Column was maintained at 25°C. The UV/Vis detector was operated at 210 nm. Flow rate of the mobile phase was 0.8 ml/min. The method offers excellent separation of two enentiomers with resolution (R) is not less than 2. The method was validated to Calculate the percentage of enantiomer excess in d-TRA (drug intermediate) was performed according to the International Conference on Harmonization (ICH) guidelines [1–4]. Calibration curves showed excellent linearity over the concentration range 0.0004 to 0.002mg/ml (40% to 200%) for d-TRA. 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-TRA were 0.05% and 0.15% respectively. Average recovery of the d-TRA was 98.93%. This method was employed in determining enantiomeric impurity of bulk drug d-TRA.
HPLC, enantiomeric excess, d-threo-Ritalinic acid (d-TRA), Methylphenidate and Dexmethylphenidate
