An Improved and Validated LC Method for Resolution of Panthenol |
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Authors: | Y M Xie J Luo X H Tang D Yang X F Huo A Liu X Hu X Song H Song |
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Institution: | 1. Department of Pharmaceutical and Biological Engineering, Sichuan University, 610065, Chengdu, China 2. Chongqing Lummy Pharmaceutical Co., Ltd., 401336, Chongqing, China 3. Sichuan Cancer Hospital, 610041, Chengdu, China
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Abstract: | An improved LC method was developed and validated for determination of enantiomeric purity of panthenol in bulk drugs. The method is based on derivatization of panthenol with 3,5-dinitrobenzoyl chloride. Baseline separation with resolution >2.7 was achieved within 20 min on Kromasil CHI-DMB (250 × 4.6 mm) column using n-hexane:ethanol (95:5 v/v) as mobile phase at a flow rate of 1.5 mL min?1. The analytes were detected by their UV absorbance at 265 nm. The effects of ethanol, 2-propanol and temperature on enantioselectivity and resolution of enantiomers were evaluated. The method was extensively validated and proved to be robust. The recoveries were between 98.3 and 101.4% with <1.6% relative standard deviation. The regression equations for the derivatives of d-panthenol and l-panthenol were y 1 = 18.01x 1 ? 32.56 (r 1 2 = 0.9984) and y 2 = 17.855x 2 ? 28.16 (r 2 2 = 0.9990), respectively. The LOD and LOQ for the derivative of d-panthenol were 10.6 and 37.4 μg mL?1 and for the derivative of l-panthenol were 12.1 and 40 μg mL?1, respectively. The improved method was found to be simple, rapid, and sensitive for the determination of enantiomeric purity of panthenol in bulk drugs. |
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