V. Goud, P. Sirisha, R. N, Ramreddy Godela, B.durga Prasad
{"title":"用稳定性指示RP-HPLC法分析替西帕肽在其散装和上市制剂中的含量","authors":"V. Goud, P. Sirisha, R. N, Ramreddy Godela, B.durga Prasad","doi":"10.25258/ijpqa.14.2.27","DOIUrl":null,"url":null,"abstract":"The core intentions of the stated work has been to create and validate a simple, sensitive, specific, precise and cost-effective RP-HPLC method with good performance for the investigation of tirzepatide in API powder and its marketed formulation. HPLC system (WATERS) equipped with DAD detection system was used to develop the current system. The procedure conditions of BDS C18 (150 x 4.6 mm,5 m), 0.01N KH2PO4: Acetonitrile in the ratio of 41:59 (% v/v), a flow of 0.9 mL/min, and a temperature of 31°C were successfully optimized by central composite design of QbD experiments. The optimized wavelength selected was 250 nm. RT of tirzepatide was observed to be 2.841 minutes with good system suitability. The ICH Q2(R1) standards functioned as a validation for the planned action strategy. Linearity was observed for 5 to 30 μg/mL concentration series of tirzepatide with R2 of 0.999. The %RSD results of both precisions were found in the range of 0.40 to 0.41.% recovery of Tirzepatide in spiked samples was assessed to be 99.89%. The LoD and LoQ of tirzepatide were calculated to be 0.05 and 0.14 μg/mL, respectively. The results assured that the established procedure was simple, sensitive, specific, accurate and costeffective. Exploration of tirzepatide under a diversity of FD conditions represents the stability representing the quality of the established HPLC procedure. Hence, the anticipated process has significant credit in the pharmaceutical segment.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"QbD Approach for Analysis of Tirzepatide in its Bulk and Marketed Formulation by Stability Indicating RP-HPLC\",\"authors\":\"V. Goud, P. Sirisha, R. N, Ramreddy Godela, B.durga Prasad\",\"doi\":\"10.25258/ijpqa.14.2.27\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The core intentions of the stated work has been to create and validate a simple, sensitive, specific, precise and cost-effective RP-HPLC method with good performance for the investigation of tirzepatide in API powder and its marketed formulation. HPLC system (WATERS) equipped with DAD detection system was used to develop the current system. The procedure conditions of BDS C18 (150 x 4.6 mm,5 m), 0.01N KH2PO4: Acetonitrile in the ratio of 41:59 (% v/v), a flow of 0.9 mL/min, and a temperature of 31°C were successfully optimized by central composite design of QbD experiments. The optimized wavelength selected was 250 nm. RT of tirzepatide was observed to be 2.841 minutes with good system suitability. The ICH Q2(R1) standards functioned as a validation for the planned action strategy. Linearity was observed for 5 to 30 μg/mL concentration series of tirzepatide with R2 of 0.999. The %RSD results of both precisions were found in the range of 0.40 to 0.41.% recovery of Tirzepatide in spiked samples was assessed to be 99.89%. The LoD and LoQ of tirzepatide were calculated to be 0.05 and 0.14 μg/mL, respectively. The results assured that the established procedure was simple, sensitive, specific, accurate and costeffective. Exploration of tirzepatide under a diversity of FD conditions represents the stability representing the quality of the established HPLC procedure. Hence, the anticipated process has significant credit in the pharmaceutical segment.\",\"PeriodicalId\":14260,\"journal\":{\"name\":\"International Journal of Pharmaceutical Quality Assurance\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-06-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Pharmaceutical Quality Assurance\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.25258/ijpqa.14.2.27\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutical Quality Assurance","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25258/ijpqa.14.2.27","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0
摘要
所述工作的核心目的是创建并验证一种简单、灵敏、特异、精确且具有成本效益的RP-HPLC方法,该方法具有良好的性能,可用于研究API粉末及其上市制剂中的替西帕肽。使用配备DAD检测系统的HPLC系统(WATERS)来开发当前的系统。通过QbD实验的中心复合设计,成功地优化了BDS C18(150 x 4.6 mm,5 m)、0.01N KH2PO4:乙腈(比例为41:59(%v/v))、0.9 mL/min流量和31°C温度的工艺条件。选择的最佳波长为250nm。观察到替西帕肽的RT为2.841分钟,具有良好的系统适用性。ICH Q2(R1)标准作为计划行动策略的验证。在5至30μg/mL浓度系列的替西帕肽中观察到线性,R2为0.999。两种精密度的%RSD结果均在0.40至0.41范围内。加标样品中替西帕肽的回收率为99.89%。计算出替西帕胺的LoD和LoQ分别为0.05和0.14μg/mL。结果表明,所建立的程序简单、灵敏、具体、准确且具有成本效益。在不同FD条件下对替西帕肽的探索代表了所建立的HPLC程序的稳定性,代表了其质量。因此,预期的过程在制药领域具有重要的信誉。
QbD Approach for Analysis of Tirzepatide in its Bulk and Marketed Formulation by Stability Indicating RP-HPLC
The core intentions of the stated work has been to create and validate a simple, sensitive, specific, precise and cost-effective RP-HPLC method with good performance for the investigation of tirzepatide in API powder and its marketed formulation. HPLC system (WATERS) equipped with DAD detection system was used to develop the current system. The procedure conditions of BDS C18 (150 x 4.6 mm,5 m), 0.01N KH2PO4: Acetonitrile in the ratio of 41:59 (% v/v), a flow of 0.9 mL/min, and a temperature of 31°C were successfully optimized by central composite design of QbD experiments. The optimized wavelength selected was 250 nm. RT of tirzepatide was observed to be 2.841 minutes with good system suitability. The ICH Q2(R1) standards functioned as a validation for the planned action strategy. Linearity was observed for 5 to 30 μg/mL concentration series of tirzepatide with R2 of 0.999. The %RSD results of both precisions were found in the range of 0.40 to 0.41.% recovery of Tirzepatide in spiked samples was assessed to be 99.89%. The LoD and LoQ of tirzepatide were calculated to be 0.05 and 0.14 μg/mL, respectively. The results assured that the established procedure was simple, sensitive, specific, accurate and costeffective. Exploration of tirzepatide under a diversity of FD conditions represents the stability representing the quality of the established HPLC procedure. Hence, the anticipated process has significant credit in the pharmaceutical segment.
期刊介绍:
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.