Determination of Optical Impurity in L-Norephedrine Hydrochloride by RP-HPLC with Pre-Column Derivatizatio

WNG Jin-zho;HU Gong-yun ;ZENG Su

Chinese Pharmaceutical Journal ›› 2009, Vol. 44 ›› Issue (16) : 1266-1268.

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PDF(1899 KB)
Chinese Pharmaceutical Journal ›› 2009, Vol. 44 ›› Issue (16) : 1266-1268.
Article

Determination of Optical Impurity in L-Norephedrine Hydrochloride by RP-HPLC with Pre-Column Derivatizatio

  • WANG Jin-zhao1, 2, HU Gong-yun ２ * , ZENG Su1
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Abstract

OBJECTIVE To establish a chiral precolumn derivatization method for optical purity test of L-norephedrine hydrochloride. METHODS The enantiomers of norephedrine hydrochloride were derivatized with a pre-column chiral derivatization reagent 2，3，4，6-tetra-O-acetyl-β-D-glucopyranosyl -isothiocyanate (GITC). The diastereoisomers produced were separated on an Agilent Zorbax C18 column (4.6 mm×250 mm，5 μm) with a mobile phase consisting of acetonitrile -0.01 mol·L-1 phosphate buffer (pH 3.0) (40∶60). The flow rate was set at 1.0 mL·min-1 and the detection wavelength was set at 210 nm. RESULTS The method was linear in the range of 0.3-5.0 mg·L-1 for the D-norephedrine hydrochloride. The lower limit of detection for D-norephedrine hydrochloride was 0.1 mg·L-1 and the lower limit of quantification was 0.3 mg·L-1. The inter- and intra-day precision (RSD) was below 5.0% and the average recovery was 98.0%. CONCLUSION The method is simple, accurate and suitable for the quality control of optical purity of L-norephedrine hydrochloride.

Key words

norephedrine / optical impurity / HPLC / pre-column derivatization

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WNG Jin-zho;HU Gong-yun ;ZENG Su . Determination of Optical Impurity in L-Norephedrine Hydrochloride by RP-HPLC with Pre-Column Derivatizatio[J]. Chinese Pharmaceutical Journal, 2009, 44(16): 1266-1268

References


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（收稿日期： 2008-12-10 ）


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