{"title":"高效液相色谱法测定糖浆剂型中富马酸酮替芬的含量","authors":"M. A. Salih, Dlivan Fatah Aziz, S. Ali","doi":"10.24017/SCIENCE.2020.ICHMS2020.7","DOIUrl":null,"url":null,"abstract":"The goal of the current study was to establish and authenticate an isocratic reverse-stage High-Performance Liquid Chromatography (HPLC) method for quantifying ketotifen fumarate (KF) in pharmaceutical liquid dosage compositions. Easy, quick, accurate, exact, and accurate reverse-stage high-performance liquid chromatography was advanced for the simultaneous assessment of ketotifen fumarate in the liquid syrup dosage type. The HPLC system using isocratic elution method with reverse-phase Inertsil ODS-(250 mm × 4.6 mm, 3 μm) column was detected by ultraviolet absorbance at 297 nm with no interference from widely using excipients, the mobile phase (A) is a mixture of triethylamine and water (175 μl in 500 ml of water), and the mobile phase (B) is a mixture of triethylamine and methanol (175 μl in 500 ml of methanol) at a flow rate of 1.5 mL/min (mobile phase A 40 %:mobile phase B 60%) at column temperature using 40 ° C, the retention time for ketotifen fumarate was 6.4±0.5 min. The concentration curves were linear in the range of 10.0 to 35.0 μg / ml (R2 = 0.9999). The developed method was tested for the specificity, precision, linearity, precision, reliability, robustness, and consistency of the solution. The regeneration of ketotifen fumarate in formulations was found to be 99.75 %, 99.91 %, and 100.05 % respectively. The percent RSD for percent recovery was found to be 0.21 and 0.17 and 0.10 for ketotifen fumarate. In the conclusion, the suggested technique was successfully used for the quantitative determination of ketotifen fumarate in formulations.","PeriodicalId":17866,"journal":{"name":"Kurdistan Journal of Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2020-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography\",\"authors\":\"M. A. Salih, Dlivan Fatah Aziz, S. Ali\",\"doi\":\"10.24017/SCIENCE.2020.ICHMS2020.7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The goal of the current study was to establish and authenticate an isocratic reverse-stage High-Performance Liquid Chromatography (HPLC) method for quantifying ketotifen fumarate (KF) in pharmaceutical liquid dosage compositions. Easy, quick, accurate, exact, and accurate reverse-stage high-performance liquid chromatography was advanced for the simultaneous assessment of ketotifen fumarate in the liquid syrup dosage type. The HPLC system using isocratic elution method with reverse-phase Inertsil ODS-(250 mm × 4.6 mm, 3 μm) column was detected by ultraviolet absorbance at 297 nm with no interference from widely using excipients, the mobile phase (A) is a mixture of triethylamine and water (175 μl in 500 ml of water), and the mobile phase (B) is a mixture of triethylamine and methanol (175 μl in 500 ml of methanol) at a flow rate of 1.5 mL/min (mobile phase A 40 %:mobile phase B 60%) at column temperature using 40 ° C, the retention time for ketotifen fumarate was 6.4±0.5 min. The concentration curves were linear in the range of 10.0 to 35.0 μg / ml (R2 = 0.9999). The developed method was tested for the specificity, precision, linearity, precision, reliability, robustness, and consistency of the solution. The regeneration of ketotifen fumarate in formulations was found to be 99.75 %, 99.91 %, and 100.05 % respectively. The percent RSD for percent recovery was found to be 0.21 and 0.17 and 0.10 for ketotifen fumarate. In the conclusion, the suggested technique was successfully used for the quantitative determination of ketotifen fumarate in formulations.\",\"PeriodicalId\":17866,\"journal\":{\"name\":\"Kurdistan Journal of Applied Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-12-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Kurdistan Journal of Applied Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.24017/SCIENCE.2020.ICHMS2020.7\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Kurdistan Journal of Applied Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.24017/SCIENCE.2020.ICHMS2020.7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
本研究的目的是建立一种等温反相高效液相色谱法(HPLC)来定量测定药液中富马酸酮替芬(KF)的含量。提出了简便、快速、准确、准确、准确的反相高效液相色谱法同时测定液体糖浆剂型中富马酸酮替芬的方法。HPLC系统采用等容洗脱法,反相Inertsil ODS-(250 mm × 4.6 mm, 3 μm)柱,在297 nm处紫外吸光度检测,无广泛使用的辅料干扰,流动相(A)为三乙胺与水的混合物(175 μl, 500 ml水);流动相(B)为三乙胺与甲醇的混合物(175 μl / 500 ml甲醇),流速为1.5 ml /min(流动相a 40%:流动相B 60%),柱温为40℃,富马酸酮替芬的保留时间为6.4±0.5 min,浓度曲线在10.0 ~ 35.0 μg / ml范围内呈线性关系(R2 = 0.9999)。对该方法的特异性、精密度、线性度、精密度、可靠性、稳健性和溶液的一致性进行了检验。富马酸酮替芬的再生率分别为99.75%、99.91%和100.05%。富马酸酮替芬回收率的RSD分别为0.21、0.17和0.10。本方法可用于复方富马酸酮替芬的定量测定。
Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
The goal of the current study was to establish and authenticate an isocratic reverse-stage High-Performance Liquid Chromatography (HPLC) method for quantifying ketotifen fumarate (KF) in pharmaceutical liquid dosage compositions. Easy, quick, accurate, exact, and accurate reverse-stage high-performance liquid chromatography was advanced for the simultaneous assessment of ketotifen fumarate in the liquid syrup dosage type. The HPLC system using isocratic elution method with reverse-phase Inertsil ODS-(250 mm × 4.6 mm, 3 μm) column was detected by ultraviolet absorbance at 297 nm with no interference from widely using excipients, the mobile phase (A) is a mixture of triethylamine and water (175 μl in 500 ml of water), and the mobile phase (B) is a mixture of triethylamine and methanol (175 μl in 500 ml of methanol) at a flow rate of 1.5 mL/min (mobile phase A 40 %:mobile phase B 60%) at column temperature using 40 ° C, the retention time for ketotifen fumarate was 6.4±0.5 min. The concentration curves were linear in the range of 10.0 to 35.0 μg / ml (R2 = 0.9999). The developed method was tested for the specificity, precision, linearity, precision, reliability, robustness, and consistency of the solution. The regeneration of ketotifen fumarate in formulations was found to be 99.75 %, 99.91 %, and 100.05 % respectively. The percent RSD for percent recovery was found to be 0.21 and 0.17 and 0.10 for ketotifen fumarate. In the conclusion, the suggested technique was successfully used for the quantitative determination of ketotifen fumarate in formulations.