反相高效液相色谱法同时测定散装和胶囊中哌醋甲酯和哌醋甲酯的分析验证和稳定性研究

IF 0.7 Q4 CHEMISTRY, ANALYTICAL
Hathibelagal Mundarinti Sudheer Kumar, Kothapalli Bannoth Chandrasekhar
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引用次数: 0

摘要

建立了一种稳定性指示的反相高效液相色谱法(RP-HPLC),用于同时测定原料药和片剂中哌甲酯(SER)和哌甲酯(DEX)的含量。SER和DEX是中枢神经系统兴奋剂。这种组合用于治疗注意缺陷多动障碍。色谱柱为Waters C18,色谱柱尺寸为250mm × 4.6,粒径为5 μm,流动相为磷酸缓冲液pH为4.8:甲醇(70:30,v/v),流速为0.8 mL/min,等吸点为215 nm。该方法的特异性、精密度、准确度、线性和稳健性均按照ICH标准进行验证。强制降解研究证实了该方法的稳定性。SER和DEX的滞留时间分别为2.390 min和4.602 min。所开发的技术被发现是专门和准确的。SER在90 ~ 270 μg/mL之间呈线性关系,DEX在17.50 ~ 52.50 μg/mL之间呈线性关系。SER的LOD和LOQ分别为6.35和21.17 μg/mL, DEX的LOD和LOQ分别为1.18和3.93 μg/mL。结果表明,所建立的高效液相色谱法定量哌甲酯右旋甲酯(SER)和哌甲酯右旋甲酯(DEX)可靠、重复性好、准确、灵敏。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical Validation and Stability Indicating Studies for Simultaneous Estimation of Serdexmethylphenidate and Dexmethylphenidate by RP-HPLC in Bulk and Capsules
A stability-indicating RP-HPLC method for the simultaneous determination of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) has been developed and validated in bulk and tablet dosage forms. SER and DEX are central nervous system stimulants. This combination is used to treat attention deficit hyperactive disorder. The chromatographic analysis was carried out on a Waters C18 Column with 250mm x 4.6 and a particle size of 5 μm, using an isocratic mobile phase of Phosphate Buffer pH 4.8: Methanol (70:30, v/v) at a flow rate of 0.8 mL/min, and the eluents were monitored at an isosbestic point of 215 nm. Specificity, precision, accuracy, linearity, and robustness of the proposed method were all validated according to ICH standards. Forced degradation studies confirmed the method's stability indicating nature. SER and DEX had retention times of 2.390 and 4.602 min, respectively. The developed technique was found to be specific and accurate. SER linearity was achieved between 90-270 μg/mL, while DEX linearity was obtained between 17.50-52.50 μg/mL. SER had LOD and LOQ of 6.35 and 21.17 μg/mL, whereas DEX had LOD and LOQ of 1.18 and 3.93 μg/mL, respectively. As a result, the suggested HPLC method for the quantification of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) was reliable, repeatable, accurate, and sensitive.
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来源期刊
CiteScore
1.00
自引率
14.30%
发文量
12
期刊介绍: The journal "Methods and objects of chemical analysis" is peer-review journal and publishes original articles of theoretical and experimental analysis on topical issues and bio-analytical chemistry, chemical and pharmaceutical analysis, as well as chemical metrology. Submitted works shall cover the results of completed studies and shall make scientific contributions to the relevant area of expertise. The journal publishes review articles, research articles and articles related to latest developments of analytical instrumentations.
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