目的 建立輔料乳糖的HPLC-RID檢測(cè)方法。方法 色譜柱為Boston Green Amino氨基鍵合硅膠柱（250 mm×4.6 mm，5 μm），流動(dòng)相為乙腈-水（70：30），體積流量1.0 mL/min，柱溫45℃；檢測(cè)器為示差折光檢測(cè)器，檢測(cè)器溫度40℃，進(jìn)樣量10 μL。結(jié)果 乳糖在0.2～5.0 mg/mL范圍內(nèi)線性關(guān)系良好（r≥0.999 8），檢測(cè)限為0.06 mg/mL，平均回收率為99.6%，相對(duì)標(biāo)準(zhǔn)偏差為0.7%。結(jié)論 該方法專(zhuān)屬性好、操作簡(jiǎn)便、快速準(zhǔn)確，適用于輔料乳糖的含量測(cè)定。

Objective To establish a method for determination of accessories lactose by HPLC-RID.Methods Boston Green Amino-NH₂ column (250 mm×4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-water (70:30). The flow rate was 1.0 mL/min. The column temperature was 45 ℃, the detector temperature was 40 ℃ and the injection volume was 10 μL.Results Lactose showed good linearity in the range of 0.2—5.0 mg/mL (r≥0.999 8). The detection limit was 0.06 mg/mL. The average recovery was 99.6% and the relative standard deviation was 0.7%.Conlusion The method is specific, convenient, fast and accurate, which can be used for determination of accessories lactose.