Uncertainty Analysis on HPLC Method for the Determination of Baicalin in Qingkailing Injection / 中国药房

ABSTRACT

OBJECTIVE: To analyze the uncertainty involved in HPLC method for the determination Baicalin in Qingkai-ling injection. METHODS: Through establishing HPLC determination mathematical model, the factors affecting the uncertainty were deduced. Each component of uncertainty was evaluated and calculated, from which the combined uncertainty and finally the extended uncertainty and confidence level were obtained. RESULTS: The combined uncertainty was 5.45?10-3, extended uncertainty was 0.01, and the determined content of Baicalin was (4.02?0.01) mg?mL-1. CONCLUSION: The established analytical method is applicable to the uncertainty analysis of HPLC method in the determination of drugs.