| 王立峰,刘尧,庄子瑜,王磊,马郑.盐酸奥洛他定滴眼液质量标准提升研究[J].中国药品标准,2019,20(5):442-447 |
| 盐酸奥洛他定滴眼液质量标准提升研究 |
| The improvement of quality standard for olotatidine hydrochloride eye drops |
| 投稿时间：2019-03-29 修订日期：2019-09-18 |
| DOI： |
| 中文关键词: 盐酸奥洛他定滴眼液、质量标准、对比研究 |
| 英文关键词: olotatidine hydrochloride eye dropsS quality standard comparative study |
| 基金项目: |
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| 中文摘要: |
| 摘要 目的：提升盐酸奥洛他定滴眼液的质量标准。方法：开展与原研制剂的对比研究。辛基硅烷键合硅胶为填充剂（Intertsil C8,5μm，4.6mm×250mm）；以0.5%十二烷基硫酸钠的磷酸盐溶液和乙腈的混合溶液[称取十二烷基硫酸钠5.0g，用0.05mol?L-1磷酸二氢钾溶液（用10%磷酸溶液调节pH至3.5）-乙腈（55:45）的混合溶液溶解并稀释至1000mL]为流动相，检测波长为299nm，柱温40℃，进样量50μL。结果：在该条件下四种已知杂质均能得到很好的分离。本品在0.2540～254.2μg?mL-1的浓度范围内，浓度与峰面积的线性关系良好。检测限为0.0508μg?mL-1，定量限为0.1270μg?mL-1。供试品溶液在24h内稳定。本品渗透压摩尔浓度在286～315mOsmol?kg-1之间。结论：方法学验证结果表明改进法符合《中国药典》技术要求,提升的质量标准适用于盐酸奥洛他定滴眼液的质量控制。 |
| 英文摘要: |
| Abstract Objective: To improve the standard of the quality control for olopatadine hydrochloride eye drops. Method: Comparative study was performed between generic drugs and original drugs. The method was conducted by HPLC with C8 column（Intertsil C8,5μm，4.6mm×250mm）. The mobile phase was consisted of phosphate buffer and acetonitrile containing 0.5% SDS[5.0g SDS was dissolved in a mixture of 0.05mol?L-1 potassium dihydrogen phosphate (adjusting pH to 3.5 with 10% phosphoric acid) and acetonitrile (55:45) in 1000 mL].The wavelength was set at 299 nm, the column temperature was 40℃ ,the injection volume was 50μL. Results: Four known impurities were separated. The liner range was 0.2540～254.2μg?mL-1 .The detection limit was 0.0508μg?mL-1 and the quantitation limit was 0.1270μg?mL-1. The test solution was stable within 24 hours. The range of osmolality was 286～315 mOsmol?kg-1.Conclusion: The validated method proved to be complying with the requirements of Chinese Pharmacopoeia. The improved quality standard was suitable for the quality control of olopatadine hydrochloride eye drops. |
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