Determination of Three Optical Isomer Impurities in (R，R)-Penehyclidine Fumarate by Reversed Phase High Performance Liquid Chromatography with Cyclodetrin as a Moble Phase Additive

WEI Jun， LOU Yan-hong， WANG Xu-guang， HE Xin-hua， ZHONG Bo-hua， XIE Jian-wei

Chinese Pharmaceutical Journal ›› 2013, Vol. 48 ›› Issue (2) : 139-142.

Chinese Pharmaceutical Journal ›› 2013, Vol. 48 ›› Issue (2) : 139-142.

Determination of Three Optical Isomer Impurities in (R，R)-Penehyclidine Fumarate by Reversed Phase High Performance Liquid Chromatography with Cyclodetrin as a Moble Phase Additive

  • WEI Jun， LOU Yan-hong， WANG Xu-guang， HE Xin-hua， ZHONG Bo-hua， XIE Jian-wei
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Abstract

OBJECTIVE To establish a reversed phase high performance liquid chromatography (RP-HPLC) method for the chiral separation and determination of (R，R)-penehyclidine fumarate and its optical isomer impurities. METHODS The chiral separation was performed on a C18 (4.6 mm ×250 mm， 5 μm) with mobile phase consisting of acetonitrile-0.05 mol·L-1phosphates buffer (0.015 mol·L-1β-cyclodextrin， 0.6% triethylamine， pH 2.3) at flow rate of 1.0 mL·min-1. The column temperature was set at 25 ℃. UV Detection wavelength was set at 206 nm. RESULTS The limit of detection (LOD) of three optical isomers was 0.09%. The established chiral HPLC method was used for the quality control of (R，R)-penehyclidine fumarate．CONCLUSION The method can be used to check and control the optical isomer impurities in the chiral drug， (R，R)-penehyclidine fumarate.

Key words

(R / R)-penehyclidine fumarate；optical isomer；high performance liquid chromatography；chiral separation

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WEI Jun， LOU Yan-hong， WANG Xu-guang， HE Xin-hua， ZHONG Bo-hua， XIE Jian-wei . Determination of Three Optical Isomer Impurities in (R，R)-Penehyclidine Fumarate by Reversed Phase High Performance Liquid Chromatography with Cyclodetrin as a Moble Phase Additive[J]. Chinese Pharmaceutical Journal, 2013, 48(2): 139-142

References

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