HPLC METHOD DEVELOPMENT AND VALIDATION FOR FORMALDEHYDE IN ENTERIC COATING OF HARD GELATIN CAPSULES

Pina E; Sousa AT; Brojo AP

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HPLC METHOD DEVELOPMENT AND VALIDATION FOR FORMALDEHYDE IN ENTERIC COATING OF HARD GELATIN CAPSULES

机译：硬明胶胶囊肠溶衣中甲醛的高效液相色谱方法开发与验证

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A reversed-phase high-performance liquid chromatography (HPLC) method for determination of formaldehyde in enteric coating of hard gelatin capsules is described and fully validated. This method entails the separation of formaldehyde as its 2,4-dinitrophenylhydrazone derivative using isocratic solvent eluition and its quantification with appropriate internal standard and ultraviolet detection. The results for selectivity, linearity, precision, accuracy and recovery were in agreement with validation parameters.

机译：描述并充分验证了反相高效液相色谱（HPLC）方法测定硬明胶胶囊肠溶衣中的甲醛含量。该方法需要使用等度溶剂洗脱分离甲醛作为其2,4-二硝基苯基hydr衍生物，并通过适当的内标和紫外线检测对其进行定量。选择性，线性，精密度，准确性和回收率的结果与验证参数一致。

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《Journal of Liquid Chromatography》 |1995年第13期|共11页
作者
Pina E; Sousa AT; Brojo AP;
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正文语种 eng
中图分类分析化学;
关键词
Liquid-chromatography; 2; 4-dinitrophenylhydrazones;

机译：液相色谱;2;4-二硝基苯基hydr;

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专利

1. HPLC METHOD DEVELOPMENT AND VALIDATION FOR FORMALDEHYDE IN ENTERIC COATING OF HARD GELATIN CAPSULES [J] . Pina E, Sousa AT, Brojo AP Journal of Liquid Chromatography . 1995,第13期

机译：硬明胶胶囊肠溶衣中甲醛的高效液相色谱方法开发与验证
2. Development and validation of a rapid stability indicating HPLC-method using monolithic stationary phase and two spectrophotometric methods for determination of antihistaminic acrivastine in capsules [J] . Ayman A. Gouda, Hisham Hashem, Thomas Jira Spectrochimica acta, Part A. Molecular and biomolecular spectroscopy . 2014,第Null期

机译：建立和验证快速稳定的HPLC方法，该方法采用整体固定相和两种分光光度法测定胶囊中抗组胺药阿瓦西汀的含量
3. Development and Validation of a Novel Ultra Performance Liquid Chromatography Method for Dissolution of Paricalcitol in Paricalcitol Soft Gelatin Capsules [J] . Bhaskara P.V Mantena, Sumathi V Rao, K.M.Ch. Appa Rao, American Journal of PharmTech Research . 2014,第2期

机译：新型超高效液相色谱法在Paricalcitol软明胶胶囊中溶解Paricalcitol的开发和验证
4. Comparison of HPLC and spectrophotometry methods on quantitative determination of formaldehyde in water based coatings [C] . Haihong Sun, Xiaomei Mo, Yemiao Qian International Conference on Manufacturing Science and Technology . 2013

机译：HPLC和分光光度法方法对水基涂料中甲醛定量测定的比较
5. Part I. Evaluation of silver as a reductive amperometric detector electrode for HPLC and FIA. Part II. Evaluation of supercritical fluid extraction (SFE) as a sample preparation technique. Part III. Development and validation of HPLC methods using supercritical fluid extraction and reversed-phase HPLC with electrochemical detection (LCEC). [D] . Schneiderman, Martin Alan. 1990

机译：第一部分：银作为HPLC和FIA的还原型安培检测器电极的评估。第二部分评价超临界流体萃取（SFE）作为样品制备技术。第三部分使用超临界流体萃取和带电化学检测的反相HPLC（LCEC）的HPLC方法的开发和验证。
6. Development and Validation of a HPLC Method for Dissolution and Stability Assay of Liquid-Filled Cyclosporine Capsule Drug Products [O] . Xiaoming Xu, Abhay Gupta, Patrick Faustino, 2013

机译：液体填充的环孢素胶囊药物产品的溶解度和稳定性测定的HPLC方法的开发和验证
7. Utilização do leito de jorro para a aplicação de revestimento entérico em cápsulas gelatinosas duras Utilization of a spouted bed for the application of enteric coating in hard gelatin capsules [O] . Gilmarcio Zimmermann Martins, Wanderley Pereira de Oliveira 2003

机译：使用喷动床在硬明胶胶囊中应用肠溶包衣

HPLC METHOD DEVELOPMENT AND VALIDATION FOR FORMALDEHYDE IN ENTERIC COATING OF HARD GELATIN CAPSULES

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