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| HPLC法测定卡波姆类口腔黏附片中盐酸利多卡因的含量 |
| Determination of Lidocaine Hydrochloride in Buccal Adhesive Tablets Containing Carbomer by HPLC |
| 投稿时间：2014-10-28 修订日期：2014-12-25 |
| DOI： |
| 中文关键词: 盐酸利多卡因 高效液相色谱法 卡波姆 口腔黏附片 |
| 英文关键词:Lidocaine hydrochloride HPLC Carbomer Buccal adhesive tablets |
| 基金项目:武汉市科技攻关计划(编号：201161038346） |
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| 中文摘要: |
| 摘 要 目的： 建立卡波姆类口腔黏附片中盐酸利多卡因的HPLC含量测定方法。方法: 通过氯化钙沉淀供试品中的卡波姆，采用Welch C18色谱柱（250 mm ×4.6 mm，5 μm），流动相为醋酸钠溶液（取冰醋酸50 ml，加水930 ml，用1 mol·L-1氢氧化钠调pH至3.40）-乙腈（70∶30）；流速1.0 ml·min-1，检测波长254 nm，柱温40℃，进样量20 μl。结果:在0.10～2.00 mg·mL-1的范围内，盐酸利多卡因的浓度与峰面积呈良好的线性关系（r=0.999 9），平均回收率为100.2%，RSD为1.4%（n=9）。结论: 本方法简单、准确、重复性好，可用于口腔黏附片中盐酸利多卡因的含量测定。 |
| 英文摘要: |
| ABSTRACT Objective: To establish a method to determine the content of lidocaine hydrochloride in buccal adhesive tablets containing carbomer as an excipient by HPLC. Methods: Calcium chloride was used to precipitate carbomer in buccal adhesive tablets. The HPLC analysis was performed on a Welch C18 column (250 mm×4.6 mm, 5 μm) with the column temperature of 40℃. The mobile phase was the mixture of0.05% sodium acetate solution (added 50 ml acetic acid into 930 ml distilled water, adjusting pH to3.40 with 1 ml·min-1 sodium hydroxide solution) and acetonitrile (70∶30). The flow rate was 1.0 ml·min-1, the detection wavelength was at 254 nm and the injection volume was 20 μl. Results: Within the range of 0.10-2.00 mg·mL-1, there was a good linear relationship between the concentration and the peak area of lidocaine hydrochloride (r=0.999 9). The average recovery was 100.2%(RSD=1.4%,n=9). Conclusion:The established method is simple, accurate and reproducible, which can be applied to determine the content of lidocaine hydrochloride in buccal adhesive tablets. |
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