{"title":"联合激素产品中戊酸雌二醇和醋酸甲孕酮的联合测定：一种新的短时间UPLC方法。","authors":"Erdal Dinç, Adem Mert","doi":"10.1093/jaoacint/qsaf016","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Hormones regulate growth, development, and reproductive functions. While deficiencies can lead to various health problems, excessive intake may cause metabolic disorders and side effects. Therefore, there is a need to develop new, reliable, and economical methods for QC and accurate analysis of hormones in tablets used for hormone replacement therapy (HRT).</p><p><strong>Objective: </strong>To develop a novel, reliable, and cost-effective, ultra-performance liquid chromatography (UPLC) method for accurately quantifying estradiol valerate (EV) and medroxyprogesterone acetate (MPG) in HRT tablets.</p><p><strong>Methods: </strong>Chromatographic separation of EV and MPG was achieved using an ACQUITY UPLC BEH C18 (1.7 μm, 2.1 × 100 mm) column and a mixture containing water-acetonitrile-methanol-0.10 M phosphate buffer pH 2.14 (6:44:42:8, v/v). Chromatographic detection was accomplished at 280.0 nm for EV and 240.0 nm for MPG, with a flow rate of 0.34 mL/min at a column temperature of 40°C. The method's validity was assessed using individual and spiked sample analyses.</p><p><strong>Results: </strong>The validated UPLC method offered an alternative procedure to quantify EV and MPG in commercial hormone tablets. This method demonstrated highly accurate and precise analytic results with a short retention time and low cost. The measured concentrations of EV and MPG in the tablet samples were found within the expected ranges, confirming the method's suitability for reliable hormone quantification in commercial tablets.</p><p><strong>Conclusion: </strong>This validated UPLC method is a cost-effective and efficient tool for routine quality control of EV and MPG in HRT tablets, ensuring reliable pharmaceutical analysis.</p><p><strong>Highlights: </strong>This study introduces the first ultra-performance liquid chromatography with photodiode array detection (UPLC-PDA) method for analyzing EV and MPG in a commercial hormone formulation. The method showed excellent assay results in the analysis of real samples.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"313-319"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Co-Estimating Estradiol Valerate and Medroxyprogesterone Acetate in a Combined Hormonal Product: A Novel Short Runtime UPLC Method.\",\"authors\":\"Erdal Dinç, Adem Mert\",\"doi\":\"10.1093/jaoacint/qsaf016\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Hormones regulate growth, development, and reproductive functions. While deficiencies can lead to various health problems, excessive intake may cause metabolic disorders and side effects. Therefore, there is a need to develop new, reliable, and economical methods for QC and accurate analysis of hormones in tablets used for hormone replacement therapy (HRT).</p><p><strong>Objective: </strong>To develop a novel, reliable, and cost-effective, ultra-performance liquid chromatography (UPLC) method for accurately quantifying estradiol valerate (EV) and medroxyprogesterone acetate (MPG) in HRT tablets.</p><p><strong>Methods: </strong>Chromatographic separation of EV and MPG was achieved using an ACQUITY UPLC BEH C18 (1.7 μm, 2.1 × 100 mm) column and a mixture containing water-acetonitrile-methanol-0.10 M phosphate buffer pH 2.14 (6:44:42:8, v/v). Chromatographic detection was accomplished at 280.0 nm for EV and 240.0 nm for MPG, with a flow rate of 0.34 mL/min at a column temperature of 40°C. The method's validity was assessed using individual and spiked sample analyses.</p><p><strong>Results: </strong>The validated UPLC method offered an alternative procedure to quantify EV and MPG in commercial hormone tablets. This method demonstrated highly accurate and precise analytic results with a short retention time and low cost. The measured concentrations of EV and MPG in the tablet samples were found within the expected ranges, confirming the method's suitability for reliable hormone quantification in commercial tablets.</p><p><strong>Conclusion: </strong>This validated UPLC method is a cost-effective and efficient tool for routine quality control of EV and MPG in HRT tablets, ensuring reliable pharmaceutical analysis.</p><p><strong>Highlights: </strong>This study introduces the first ultra-performance liquid chromatography with photodiode array detection (UPLC-PDA) method for analyzing EV and MPG in a commercial hormone formulation. The method showed excellent assay results in the analysis of real samples.</p>\",\"PeriodicalId\":94064,\"journal\":{\"name\":\"Journal of AOAC International\",\"volume\":\" \",\"pages\":\"313-319\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of AOAC International\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/jaoacint/qsaf016\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of AOAC International","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/jaoacint/qsaf016","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Co-Estimating Estradiol Valerate and Medroxyprogesterone Acetate in a Combined Hormonal Product: A Novel Short Runtime UPLC Method.
Background: Hormones regulate growth, development, and reproductive functions. While deficiencies can lead to various health problems, excessive intake may cause metabolic disorders and side effects. Therefore, there is a need to develop new, reliable, and economical methods for QC and accurate analysis of hormones in tablets used for hormone replacement therapy (HRT).
Objective: To develop a novel, reliable, and cost-effective, ultra-performance liquid chromatography (UPLC) method for accurately quantifying estradiol valerate (EV) and medroxyprogesterone acetate (MPG) in HRT tablets.
Methods: Chromatographic separation of EV and MPG was achieved using an ACQUITY UPLC BEH C18 (1.7 μm, 2.1 × 100 mm) column and a mixture containing water-acetonitrile-methanol-0.10 M phosphate buffer pH 2.14 (6:44:42:8, v/v). Chromatographic detection was accomplished at 280.0 nm for EV and 240.0 nm for MPG, with a flow rate of 0.34 mL/min at a column temperature of 40°C. The method's validity was assessed using individual and spiked sample analyses.
Results: The validated UPLC method offered an alternative procedure to quantify EV and MPG in commercial hormone tablets. This method demonstrated highly accurate and precise analytic results with a short retention time and low cost. The measured concentrations of EV and MPG in the tablet samples were found within the expected ranges, confirming the method's suitability for reliable hormone quantification in commercial tablets.
Conclusion: This validated UPLC method is a cost-effective and efficient tool for routine quality control of EV and MPG in HRT tablets, ensuring reliable pharmaceutical analysis.
Highlights: This study introduces the first ultra-performance liquid chromatography with photodiode array detection (UPLC-PDA) method for analyzing EV and MPG in a commercial hormone formulation. The method showed excellent assay results in the analysis of real samples.
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