摘 要：建立以高效液相色譜法（HPLC）測定帕瑞昔布鈉中有關物質的方法。色譜柱為C18柱（4.6 mm×250 mm×5 μm），乙腈-0.01 mol/L磷酸氫二鈉溶液（用磷酸調節pH值至3.0）（47∶53，ν∶ν）為流動相，檢測波長為215 nm，柱溫40 ℃。經過優化色譜條件后，帕瑞昔布鈉峰與6個已知雜質峰均可達到基線分離，樣品主峰及各雜質的色譜峰的靈敏度和分離度均滿足測定要求。采用HPLC法測定帕瑞昔布鈉中的有關物質，專屬性強，方法靈敏度高，結果準確可靠。
關鍵詞：HPLC法；帕瑞昔布鈉；雜質；代地昔布
文獻標志碼：A 文章編號：1674-5124（2015）12-0054-05
Research on HPLC method for related substances in parecoxib sodium
NIE Zhongli1， GUO Zhaoyuan2， XIAO Maoling1， WANG Xiaoling3， ZHANG Yong3， GUO Rui3， YE Ding3
（1. School of Pharmacy and Bioengineering，Chengdu University，Chengdu 610106，China；
2. Sichuan Industrial Institute of Antibiotics，Chengdu University，Chengdu 610106，China；
3. Chengdu Climb Pharmaceutical Technology Co.，Ltd.，Chengdu 610041，China）
Abstract: To determine related substances in parecoxib sodium with high performance liquid chromatograph（HPLC）. C18 column has been used as filler （4.6 mm×250 mm×5 μm） and acetonitrile -0.01 mol/L ammonium dihydrogen phosphate （adjusted to pH 3.0 with phosphoric acid） （47∶53，ν∶ν） as mobile phase. The detection wavelength was set at 215 nm and the column temperature 40 ℃. After the optimization of chromatographic conditions， the parecoxib sodium peak and 6 known impurity peaks meet the requirement of baseline separation. The sensitivity and resolution of the main peak of the samples and the chromatographic peak of all the impurities are both acceptable. The HPLC method is specific and reliable.
Keywords: HPLC method； parecoxib sodium； impurities； valdecoxib
