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Orthogonal Design-Directed Optimization of an LC Method for Fingerprinting Mai-Luo-Ning Injection, and Validation of the Method

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Abstract

A novel hierarchical chromatographic response function (HCRF)-directed orthogonal design procedure has been used for optimization of an high-performance liquid chromatography method for fingerprinting Mai-Luo-Ning (MLN) injection. The method was then successfully validated. Five major controllable chromatographic conditions at four levels were included in the orthogonal design. A total of 16 chromatographic runs resulted in the optimum chromatographic conditions-a 250 × 4.6 mm i.d., 4-μm particle, C18 column, a mixture of methanol and 0.025% aqueous formic acid in water as mobile phase, flow rate 0.8 mL min−1, column temperature 35 °C, and detection wavelength 240 nm. The mobile phase gradient was then further optimized step by step by observation of the chromatographic profiles obtained. Fingerprints of MLN injection and its constituent single herb injections were separately acquired by use of the optimized method. Attribution of the 18 largest peaks observed in the MLN fingerprint indicated that Flos Lonicerae was the main ingredient. Validation of the method for precision, repeatability, and stability proved it was highly reproducible. This chromatography fingerprint method could be very useful for quality control of MLN injection. The original HCRF-directed orthogonal design approach proposed should be generally useful for developing chromatographic fingerprinting methods.

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Acknowledgments

This work was supported financially by National Natural Science Foundation of China (nos. 30572228 and 30630076) and the “eleventh five-years” supporting programs from the Ministry of Science and Technology of the P.R. China (no. 2006BAI08B04-05). We thank Professor Fenzhi Sun and Dr. Fang Zhou for editorial assistance.

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Authors and Affiliations

  1. Key Laboratory of Drug Metabolism and Pharmacokinetics E04#, China Pharmaceutical University, Nanjing, 210038, China

    Nan Cui, Haiping Hao, Guangji Wang, Wei Wang & Yuxin Wang

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  1. Nan Cui
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  2. Haiping Hao
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  3. Guangji Wang
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  4. Wei Wang
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  5. Yuxin Wang
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Correspondence to Haiping Hao.

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Cui, N., Hao, H., Wang, G. et al. Orthogonal Design-Directed Optimization of an LC Method for Fingerprinting Mai-Luo-Ning Injection, and Validation of the Method. Chroma 68, 33–39 (2008). https://doi.org/10.1365/s10337-008-0650-2

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