{"title":"酒石酸布托诺啡的紫外分光光度法开发与验证","authors":"Sonu Ahirwar, Varsha Kashaw, Ravish Sahu, Surbhi Chourasia, Vaibhav Rajoria, Prakash Kushwaha","doi":"10.22270/jddt.v14i4.6521","DOIUrl":null,"url":null,"abstract":"The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes. \nKeywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines.","PeriodicalId":15622,"journal":{"name":"Journal of Drug Delivery and Therapeutics","volume":"52 35","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation\",\"authors\":\"Sonu Ahirwar, Varsha Kashaw, Ravish Sahu, Surbhi Chourasia, Vaibhav Rajoria, Prakash Kushwaha\",\"doi\":\"10.22270/jddt.v14i4.6521\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes. \\nKeywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines.\",\"PeriodicalId\":15622,\"journal\":{\"name\":\"Journal of Drug Delivery and Therapeutics\",\"volume\":\"52 35\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Drug Delivery and Therapeutics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22270/jddt.v14i4.6521\",\"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 Drug Delivery and Therapeutics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22270/jddt.v14i4.6521","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
本研究讨论了酒石酸丁吗啡紫外分光光度法的开发和验证。该方法简单、准确、经济，适用于酒石酸丁吗啡片剂的测定。确定了分析该药物的最佳条件。发现最大波长（λ max）为 278nm。酒石酸丁吗啡醇的回收率为 100.016±0.68。在 2-12μg/ml 浓度范围内符合比尔定律。校准曲线显示吸光度与浓度之间呈线性关系。线性方程为 y = 0.0674x - 0.0057，r2 为 0.9998。根据 ICH 指南对线性、准确度、精密度、LOD 和 LOQ 进行了验证。样品溶液的稳定性可达 36 小时。该方法适用于酒石酸丁吗啡片剂的质量控制。关键词酒石酸布托诺啡，验证，精密度，准确度，LOQ，LOD，ICH指南。
UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation
The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes.
Keywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines.
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