{"title":"HSPiP 和质量设计辅助优化生物分析方法的开发,用于从血浆样品中定量检测两性霉素 B","authors":"Mohhammad Ramzan , Tasneem Khan , Arusha Ayub , Mudassar Shahid","doi":"10.1016/j.jksus.2024.103546","DOIUrl":null,"url":null,"abstract":"<div><div>Amphotericin-b (AmB) is a broad-spectrum polyene macrolide antifungal and anti-<em>Leishmaniosis</em>. We addressed HSPiP and QbD (quality by design) oriented HPLC (high-performance liquid chromatography) method development and validation, followed by identifying critical attributes on retention time (RT) and peak area (PA). Various quality control parameters were estimated, such as the LLOQ (lower limit of quantification) and LLOD (lower limit of detection). HSPiP and experimental solubility data were the best fit in the prediction. QbD identified acetic acid (AA) pH, column temperature, and flow rate as the prime factors having an impact on PA and RT. The optimized mobile phase included AA, acetonitrile, and methanol (05:85:10) at pH 5 fluxed into the column maintained at 30 °C. The method was sensitive, as evidenced by the low values of LLOQ (1.6 ng/mL) and LLOD (10 ng/mL) and high recovery from the plasma. The method determined pharmacokinetic parameters from the rat plasma with high accuracy, precision, robustness, sensitivity, and reproducibility.</div></div>","PeriodicalId":16205,"journal":{"name":"Journal of King Saud University - Science","volume":"36 11","pages":"Article 103546"},"PeriodicalIF":3.7000,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"HSPiP and quality by design aided optimized bioanalytical method development for amphotericin B quantification from plasma samples\",\"authors\":\"Mohhammad Ramzan , Tasneem Khan , Arusha Ayub , Mudassar Shahid\",\"doi\":\"10.1016/j.jksus.2024.103546\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>Amphotericin-b (AmB) is a broad-spectrum polyene macrolide antifungal and anti-<em>Leishmaniosis</em>. We addressed HSPiP and QbD (quality by design) oriented HPLC (high-performance liquid chromatography) method development and validation, followed by identifying critical attributes on retention time (RT) and peak area (PA). Various quality control parameters were estimated, such as the LLOQ (lower limit of quantification) and LLOD (lower limit of detection). HSPiP and experimental solubility data were the best fit in the prediction. QbD identified acetic acid (AA) pH, column temperature, and flow rate as the prime factors having an impact on PA and RT. The optimized mobile phase included AA, acetonitrile, and methanol (05:85:10) at pH 5 fluxed into the column maintained at 30 °C. The method was sensitive, as evidenced by the low values of LLOQ (1.6 ng/mL) and LLOD (10 ng/mL) and high recovery from the plasma. The method determined pharmacokinetic parameters from the rat plasma with high accuracy, precision, robustness, sensitivity, and reproducibility.</div></div>\",\"PeriodicalId\":16205,\"journal\":{\"name\":\"Journal of King Saud University - Science\",\"volume\":\"36 11\",\"pages\":\"Article 103546\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-11-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of King Saud University - Science\",\"FirstCategoryId\":\"103\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1018364724004580\",\"RegionNum\":3,\"RegionCategory\":\"综合性期刊\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MULTIDISCIPLINARY SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of King Saud University - Science","FirstCategoryId":"103","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1018364724004580","RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MULTIDISCIPLINARY SCIENCES","Score":null,"Total":0}
HSPiP and quality by design aided optimized bioanalytical method development for amphotericin B quantification from plasma samples
Amphotericin-b (AmB) is a broad-spectrum polyene macrolide antifungal and anti-Leishmaniosis. We addressed HSPiP and QbD (quality by design) oriented HPLC (high-performance liquid chromatography) method development and validation, followed by identifying critical attributes on retention time (RT) and peak area (PA). Various quality control parameters were estimated, such as the LLOQ (lower limit of quantification) and LLOD (lower limit of detection). HSPiP and experimental solubility data were the best fit in the prediction. QbD identified acetic acid (AA) pH, column temperature, and flow rate as the prime factors having an impact on PA and RT. The optimized mobile phase included AA, acetonitrile, and methanol (05:85:10) at pH 5 fluxed into the column maintained at 30 °C. The method was sensitive, as evidenced by the low values of LLOQ (1.6 ng/mL) and LLOD (10 ng/mL) and high recovery from the plasma. The method determined pharmacokinetic parameters from the rat plasma with high accuracy, precision, robustness, sensitivity, and reproducibility.
期刊介绍:
Journal of King Saud University – Science is an official refereed publication of King Saud University and the publishing services is provided by Elsevier. It publishes peer-reviewed research articles in the fields of physics, astronomy, mathematics, statistics, chemistry, biochemistry, earth sciences, life and environmental sciences on the basis of scientific originality and interdisciplinary interest. It is devoted primarily to research papers but short communications, reviews and book reviews are also included. The editorial board and associated editors, composed of prominent scientists from around the world, are representative of the disciplines covered by the journal.