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Vol. 32 No. 1 (2020): Vol 32 Issue 1

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Reverse Phase Chiral HPLC Method for Enantiomeric Excess Determination of 2-Aminobutanamide

https://doi.org/10.14233/ajchem.2020.22282
T. Naga Jhansi
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India; Dr. Reddy′s Laboratories Ltd., Visakhapatnam-530045, India
D. Pavan Kumar
Dr. Reddy′s Laboratories Ltd., Visakhapatnam-530045, India
Nagaraju Rajana
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India; Dr. Reddy′s Laboratories Ltd., Visakhapatnam-530045, India
D. Jayadeep Kumar
Dr. Reddy′s Laboratories Ltd., Visakhapatnam-530045, India
G. Nageswara Rao
Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam-530003, India

Corresponding Author(s) : T. Naga Jhansi

jhansireddyau@gmail.com; tnagajhansi@drreddys.com

Asian Journal of Chemistry, Vol. 32 No. 1 (2020): Vol 32 Issue 1

Abstract

A reverse phase chiral HPLC method was developed for the determination of (R)-2-aminobutanamide isomer content in (S)-2-amino-butanamide key starting material for levetiracetam drug substance by using a CROWNPAK CR (+) column. Perchloric acid solution (0.05 %) was used as mobile phase and the flow rate was finalized as 0.3 mL/min. UV detection wavelength was 200 nm and column temperature was set as 15 ºC. The limit of detection and limit of quantification were 0.0002 mg/mL and 0.0005 mg/mL, respectively. The linearity calibration curve of (R)-2-aminobutanamide was shown good from the range of 0.0005 mg/mL to 0.004 mg/mL. The recovery of (R)-2-aminobutanamide isomer was between the range of 93 to 106 % in presence of (S)-2-aminobutanamide. The method was validated and found to be precise, accurate and robust. The method can be used for determination of (R)-2-aminobutanamide in presence of (S)-2-aminobutanamide, which is the key intermediate for preparation of levetiracetam. This method was validated in as per ICH Q2 (R1) and USP validation of compendial methods (1225).

Keywords

2-Aminobutanamide Levetiracetam Enantiomer Chiral HPLC
Jhansi, T. N., Kumar, D. P., Rajana, N., Kumar, D. J., & Rao, G. N. (2019). Reverse Phase Chiral HPLC Method for Enantiomeric Excess Determination of 2-Aminobutanamide. Asian Journal of Chemistry, 32(1), 69–72. https://doi.org/10.14233/ajchem.2020.22282
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