{"title":"DoE指导下开发的高效液相色谱法评价阿莫西林和甲硝唑共载粘着剂GRDDS根除幽门螺杆菌的疗效","authors":"Ashutosh Gupta, Prerana D. Navti, Srinivas Mutalik, Moumita Saha, Sudheer Moorkoth","doi":"10.1007/s10337-023-04290-z","DOIUrl":null,"url":null,"abstract":"<div><p><i>H. Pylori</i> infection is a major reason for chronic Peptic Ulcer Disease (PUD) and related complications worldwide. Traditional treatment options fail to eradicate the organism completely which leads to antibiotic resistance. Novel formulations are being developed with an aim for effective treatment. Mucoadhesive GRDDS system is an option to increase the antibiotic bioavailability. The objective of this work is to develop a RP-HPLC–PDA based analytical method to evaluate the entrapment efficiency of the GRDDS systems developed for <i>H. pylori</i> treatment containing amoxicillin and metronidazole. DoE was used for optimizing the HPLC conditions. The optimized method used a HyperClone ODS C<sub>18</sub> column as stationary phase and methanol: phosphate buffer (15:85) at pH 6.4 as the mobile phase. The flow rate was 0.9 mL/min. Method was validated as per the ICH Q2(R1) guideline. Method was linear from 0.5 to 20 µg/ml for both amoxicillin and metronidazole with an R<sup>2</sup> value of 0.9995 and 0.9996 respectively. The validated HPLC method showed specificity for both drugs in the presence of degradation products as well as from other excipients of the GRDDS system. The validated method was applied to determine the entrapment efficiency as a part of formulation optimization. The entrapment efficiency of the final formulation was determined to be 78–84% and 75–82% for amoxicillin and metronidazole respectively.</p><h3>Graphical Abstract</h3>\n <div><figure><div><div><picture><source><img></source></picture></div></div></figure></div>\n </div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"86 11-12","pages":"729 - 742"},"PeriodicalIF":1.2000,"publicationDate":"2023-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"DoE Guided Development of an HPLC Method for Evaluation of Amoxicillin and Metronidazole Co-loaded Mucoadhesive GRDDS Formulation for H. pylori Eradication\",\"authors\":\"Ashutosh Gupta, Prerana D. Navti, Srinivas Mutalik, Moumita Saha, Sudheer Moorkoth\",\"doi\":\"10.1007/s10337-023-04290-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p><i>H. Pylori</i> infection is a major reason for chronic Peptic Ulcer Disease (PUD) and related complications worldwide. Traditional treatment options fail to eradicate the organism completely which leads to antibiotic resistance. Novel formulations are being developed with an aim for effective treatment. Mucoadhesive GRDDS system is an option to increase the antibiotic bioavailability. The objective of this work is to develop a RP-HPLC–PDA based analytical method to evaluate the entrapment efficiency of the GRDDS systems developed for <i>H. pylori</i> treatment containing amoxicillin and metronidazole. DoE was used for optimizing the HPLC conditions. The optimized method used a HyperClone ODS C<sub>18</sub> column as stationary phase and methanol: phosphate buffer (15:85) at pH 6.4 as the mobile phase. The flow rate was 0.9 mL/min. Method was validated as per the ICH Q2(R1) guideline. Method was linear from 0.5 to 20 µg/ml for both amoxicillin and metronidazole with an R<sup>2</sup> value of 0.9995 and 0.9996 respectively. The validated HPLC method showed specificity for both drugs in the presence of degradation products as well as from other excipients of the GRDDS system. The validated method was applied to determine the entrapment efficiency as a part of formulation optimization. The entrapment efficiency of the final formulation was determined to be 78–84% and 75–82% for amoxicillin and metronidazole respectively.</p><h3>Graphical Abstract</h3>\\n <div><figure><div><div><picture><source><img></source></picture></div></div></figure></div>\\n </div>\",\"PeriodicalId\":518,\"journal\":{\"name\":\"Chromatographia\",\"volume\":\"86 11-12\",\"pages\":\"729 - 742\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2023-10-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chromatographia\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s10337-023-04290-z\",\"RegionNum\":4,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chromatographia","FirstCategoryId":"92","ListUrlMain":"https://link.springer.com/article/10.1007/s10337-023-04290-z","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
DoE Guided Development of an HPLC Method for Evaluation of Amoxicillin and Metronidazole Co-loaded Mucoadhesive GRDDS Formulation for H. pylori Eradication
H. Pylori infection is a major reason for chronic Peptic Ulcer Disease (PUD) and related complications worldwide. Traditional treatment options fail to eradicate the organism completely which leads to antibiotic resistance. Novel formulations are being developed with an aim for effective treatment. Mucoadhesive GRDDS system is an option to increase the antibiotic bioavailability. The objective of this work is to develop a RP-HPLC–PDA based analytical method to evaluate the entrapment efficiency of the GRDDS systems developed for H. pylori treatment containing amoxicillin and metronidazole. DoE was used for optimizing the HPLC conditions. The optimized method used a HyperClone ODS C18 column as stationary phase and methanol: phosphate buffer (15:85) at pH 6.4 as the mobile phase. The flow rate was 0.9 mL/min. Method was validated as per the ICH Q2(R1) guideline. Method was linear from 0.5 to 20 µg/ml for both amoxicillin and metronidazole with an R2 value of 0.9995 and 0.9996 respectively. The validated HPLC method showed specificity for both drugs in the presence of degradation products as well as from other excipients of the GRDDS system. The validated method was applied to determine the entrapment efficiency as a part of formulation optimization. The entrapment efficiency of the final formulation was determined to be 78–84% and 75–82% for amoxicillin and metronidazole respectively.
期刊介绍：
Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.
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