{"title":"优化并验证了RP-UPLC法莫替丁含量测定方法的稳定性","authors":"Tummala Vijaya Bhaskara Reddy, Nallagari Sowjanya Reddy, Sanivarapu Ravi Prakash Reddy, Golkonda Ramu, Chintala Rambabu","doi":"10.1016/j.jopr.2013.08.003","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Famotidine (FMD) is a histamine H<sub>2</sub>-receptor antagonist that inhibits stomach acid production, and it is commonly used in the treatment of peptic ulcer disease and gastro esophageal reflux disease. The main objective of the present investigation is to develop a rapid, precise and accurate stability indicating ultra performance liquid chromatographic method for the analysis of pharmaceutical formulations.</p></div><div><h3>Methods</h3><p>Waters-Alliance Ultra Performance Liquid Chromatographic system equipped with Auto Sampler, PDA detector, detection at a wavelength of 297 nm, Symmetry C18 (2.1 × 50 mm, 1.7 μm, Make: BEH) column and mobile phase of potassium dihydrogen phosphate buffer of pH = 7.0 and acetonitrile in the ratio 40:60 v/v at a flow rate of 0.2 per minute was used for the assay of famotidine in tablets by a reverse phase ultra performance liquid chromatographic method (RP-UPLC).</p></div><div><h3>Results and discussion</h3><p>The system suitable parameters such as tailing factor and theoretical plate count were found to 1.48 and 8896 respectively under the optimized experimental conditions. The retention time of the compound was observed to be 0.595 min. The developed method was proved to be precise and accurate by calculating percent of relative standard deviation (% RSD is equal to 0.900%) for six replicate injections and mean recovery (99.8%) of famotidine at three different concentration levels. Linearity between peak area and concentration was found to be 5.0–20.0 μg/mL. The limit of detection (LOD) and limit of quantitation (LOQ) values were found to be 0.006 μg/mL and 0.02 μg/mL respectively. The drug was found to be stable (81.37%–93.44%) under different degradation conditions like acid (0.1 N HCl), alkali (0.1 N NaOH), peroxide (3% H<sub>2</sub>O<sub>2</sub>), photolytic and thermal.</p></div><div><h3>Conclusions</h3><p>The developed method was found to be simple, rapid, repeatable, reproducible, robust, rugged and economic hence it can be used as a new analytical method for the analysis of pharmaceutical formulations in any pharmaceutical industries.</p></div>","PeriodicalId":16787,"journal":{"name":"Journal of Pharmacy Research","volume":"6 8","pages":"Pages 865-869"},"PeriodicalIF":0.0000,"publicationDate":"2013-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.jopr.2013.08.003","citationCount":"7","resultStr":"{\"title\":\"Optimized and validated stability indicating RP-UPLC method for the determination of famotidine in pharmaceutical formulations\",\"authors\":\"Tummala Vijaya Bhaskara Reddy, Nallagari Sowjanya Reddy, Sanivarapu Ravi Prakash Reddy, Golkonda Ramu, Chintala Rambabu\",\"doi\":\"10.1016/j.jopr.2013.08.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Famotidine (FMD) is a histamine H<sub>2</sub>-receptor antagonist that inhibits stomach acid production, and it is commonly used in the treatment of peptic ulcer disease and gastro esophageal reflux disease. The main objective of the present investigation is to develop a rapid, precise and accurate stability indicating ultra performance liquid chromatographic method for the analysis of pharmaceutical formulations.</p></div><div><h3>Methods</h3><p>Waters-Alliance Ultra Performance Liquid Chromatographic system equipped with Auto Sampler, PDA detector, detection at a wavelength of 297 nm, Symmetry C18 (2.1 × 50 mm, 1.7 μm, Make: BEH) column and mobile phase of potassium dihydrogen phosphate buffer of pH = 7.0 and acetonitrile in the ratio 40:60 v/v at a flow rate of 0.2 per minute was used for the assay of famotidine in tablets by a reverse phase ultra performance liquid chromatographic method (RP-UPLC).</p></div><div><h3>Results and discussion</h3><p>The system suitable parameters such as tailing factor and theoretical plate count were found to 1.48 and 8896 respectively under the optimized experimental conditions. The retention time of the compound was observed to be 0.595 min. The developed method was proved to be precise and accurate by calculating percent of relative standard deviation (% RSD is equal to 0.900%) for six replicate injections and mean recovery (99.8%) of famotidine at three different concentration levels. Linearity between peak area and concentration was found to be 5.0–20.0 μg/mL. The limit of detection (LOD) and limit of quantitation (LOQ) values were found to be 0.006 μg/mL and 0.02 μg/mL respectively. The drug was found to be stable (81.37%–93.44%) under different degradation conditions like acid (0.1 N HCl), alkali (0.1 N NaOH), peroxide (3% H<sub>2</sub>O<sub>2</sub>), photolytic and thermal.</p></div><div><h3>Conclusions</h3><p>The developed method was found to be simple, rapid, repeatable, reproducible, robust, rugged and economic hence it can be used as a new analytical method for the analysis of pharmaceutical formulations in any pharmaceutical industries.</p></div>\",\"PeriodicalId\":16787,\"journal\":{\"name\":\"Journal of Pharmacy Research\",\"volume\":\"6 8\",\"pages\":\"Pages 865-869\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2013-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.jopr.2013.08.003\",\"citationCount\":\"7\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pharmacy Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S097469431300323X\",\"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 Pharmacy Research","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S097469431300323X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 7
摘要
法莫替丁(FMD)是一种抑制胃酸产生的组胺h2受体拮抗剂，常用于治疗消化性溃疡病和胃食管反流病。本研究的主要目的是建立一种快速、精确、准确、稳定性指示的超高效液相色谱分析方法。MethodsWaters-Alliance超高液相色谱系统配备自动取样器,PDA检测器,检测波长297 nm,对称C18(2.1×50毫米,1.7μm,:本·)列和磷酸二氢钾缓冲液的流动相pH = 7.0和乙腈比例40:6 0 v / v 0.2每分钟的流量是用于测定法莫替丁在平板电脑市场的反向阶段超高效液相色谱测定方法(RP-UPLC)。结果与讨论在优化的试验条件下，系统的适宜参数尾矿系数和理论板数分别为1.48和8896。法莫替丁在3种不同浓度下的平均回收率(99.8%)和6次重复注射的相对标准偏差(% RSD = 0.900%)证明了该方法的精密度和准确性。峰面积与浓度呈5.0 ~ 20.0 μg/mL的线性关系。检测限和定量限分别为0.006 μg/mL和0.02 μg/mL。在酸(0.1 N HCl)、碱(0.1 N NaOH)、过氧化物(3% H2O2)、光解和热降解条件下，该药物的稳定性为81.37% ~ 93.44%。结论该方法简便、快速、重复性好、可重复性好、稳健性好、经济可靠，可作为一种新的分析方法，应用于各医药行业的制剂分析。
Optimized and validated stability indicating RP-UPLC method for the determination of famotidine in pharmaceutical formulations
Background
Famotidine (FMD) is a histamine H2-receptor antagonist that inhibits stomach acid production, and it is commonly used in the treatment of peptic ulcer disease and gastro esophageal reflux disease. The main objective of the present investigation is to develop a rapid, precise and accurate stability indicating ultra performance liquid chromatographic method for the analysis of pharmaceutical formulations.
Methods
Waters-Alliance Ultra Performance Liquid Chromatographic system equipped with Auto Sampler, PDA detector, detection at a wavelength of 297 nm, Symmetry C18 (2.1 × 50 mm, 1.7 μm, Make: BEH) column and mobile phase of potassium dihydrogen phosphate buffer of pH = 7.0 and acetonitrile in the ratio 40:60 v/v at a flow rate of 0.2 per minute was used for the assay of famotidine in tablets by a reverse phase ultra performance liquid chromatographic method (RP-UPLC).
Results and discussion
The system suitable parameters such as tailing factor and theoretical plate count were found to 1.48 and 8896 respectively under the optimized experimental conditions. The retention time of the compound was observed to be 0.595 min. The developed method was proved to be precise and accurate by calculating percent of relative standard deviation (% RSD is equal to 0.900%) for six replicate injections and mean recovery (99.8%) of famotidine at three different concentration levels. Linearity between peak area and concentration was found to be 5.0–20.0 μg/mL. The limit of detection (LOD) and limit of quantitation (LOQ) values were found to be 0.006 μg/mL and 0.02 μg/mL respectively. The drug was found to be stable (81.37%–93.44%) under different degradation conditions like acid (0.1 N HCl), alkali (0.1 N NaOH), peroxide (3% H2O2), photolytic and thermal.
Conclusions
The developed method was found to be simple, rapid, repeatable, reproducible, robust, rugged and economic hence it can be used as a new analytical method for the analysis of pharmaceutical formulations in any pharmaceutical industries.
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