{"title":"Simultaneous estimation of remogliflozin etabonate and vildagliptin in a tablet formulation: UV spectrophotometric and HPLC-PDA method","authors":"R. Kotadiya, Prachi Joshi","doi":"10.25135/jcm.82.2301.2693","DOIUrl":null,"url":null,"abstract":": Objectives: The ultraviolet spectrophotometric and reversed-phase high-performance liquid chromatography methods were developed and validated to quantify remogliflozin etabonate and vildagliptin in a fixed-dose tablet formulation. The materials and methods used in this study involved using methanol as the solvent in developing three ultraviolet spectrophotometric techniques, namely simultaneous equation, absorption ratio, and derivative spectroscopy. The wavelength maxima for vildagliptin and remogliflozin etabonate were determined to be 232 nm and 217 nm, respectively. The chromatographic method involved using a Phenomenex Luna C18 column (250 × 4.6 mm, 5 µm) and a mobile phase consisting of a mixture of methanol and acetate buffer (pH 5.6) in a 70:30 ratio. The flow rate was set at 1 mL/min, and the detecting wavelength was 210 nm. The results obtained from the optimized approaches met the performance test criteria set by the International Conference on Harmonization guideline Q2 (R1). The methods were then applied to assay marketed tablet formulations, and the results obtained were within acceptable limits. In conclusion, the developed techniques can be used to analyze the fixed-dose tablet formulation regularly.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2023-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Chemical Metrology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25135/jcm.82.2301.2693","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0
Abstract
: Objectives: The ultraviolet spectrophotometric and reversed-phase high-performance liquid chromatography methods were developed and validated to quantify remogliflozin etabonate and vildagliptin in a fixed-dose tablet formulation. The materials and methods used in this study involved using methanol as the solvent in developing three ultraviolet spectrophotometric techniques, namely simultaneous equation, absorption ratio, and derivative spectroscopy. The wavelength maxima for vildagliptin and remogliflozin etabonate were determined to be 232 nm and 217 nm, respectively. The chromatographic method involved using a Phenomenex Luna C18 column (250 × 4.6 mm, 5 µm) and a mobile phase consisting of a mixture of methanol and acetate buffer (pH 5.6) in a 70:30 ratio. The flow rate was set at 1 mL/min, and the detecting wavelength was 210 nm. The results obtained from the optimized approaches met the performance test criteria set by the International Conference on Harmonization guideline Q2 (R1). The methods were then applied to assay marketed tablet formulations, and the results obtained were within acceptable limits. In conclusion, the developed techniques can be used to analyze the fixed-dose tablet formulation regularly.
:目的:建立并验证了紫外分光光度法和反相高效液相色谱法对固定剂量片剂中的依泊净和维达格利汀进行定量。本研究中使用的材料和方法包括以甲醇为溶剂开发三种紫外分光光度法,即联立方程、吸收比和导数光谱法。维达列汀和瑞格列嗪依他波酸的最大波长分别为232nm和217nm。色谱方法包括使用Phenomenex Luna C18柱(250×4.6 mm,5µm)和流动相,流动相由甲醇和乙酸缓冲液(pH 5.6)的混合物组成,比例为70:30。流速设定为1mL/min,检测波长为210nm。从优化方法中获得的结果符合国际协调会议准则Q2(R1)制定的性能测试标准。然后将这些方法应用于市场上销售的片剂配方的测定,得到的结果在可接受的限度内。总之,所开发的技术可以用于定期分析固定剂量片剂的配方。