磷酸西他列汀和达格列嗪丙二醇固定剂量复方双层片同时定量分析反相高效液相色谱法的建立与验证

IF 0.7 4区医学 Q4 PHARMACOLOGY & PHARMACY

Current Pharmaceutical Analysis Pub Date : 2023-04-17 DOI:10.2174/1573412919666230417081123

Joo-Eun Kim, So-Jin Kang

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引用次数: 0

摘要

磷酸西他列汀一水合物达格列嗪丙二醇水合物固定酶组合（FDC）双层片用于治疗2型糖尿病。同时定量分析可以缩短磷酸西格列汀一水合物达格列嗪丙二醇一水合物FDC双层片的分析时间，提高其效率。本研究旨在对治疗2型糖尿病的西他列汀磷酸一水合物达格列嗪丙二醇一水合物FDC双层片进行同时定量分析。采用快速选择性反相高效液相色谱（RP-HPLC）方法进行了同时定量分析，并通过方法验证进行了验证。使用超强力吸收分光光度计和Zorbax C18柱（4.6 x 150 mm，5µm）进行RP-HPLC分析。流速和注射体积分别设定为1.5 mLmin-1和20µL。波长设定为205nm。西他列汀磷酸酯一水合物和达格列嗪丙二醇一水合物的保留时间分别为2.28分钟和10.65分钟。同时定量分析验证系统适用性的相对标准偏差为磷酸西格列汀一水合物和达格列嗪丙二醇一水合物0.03%。色谱图证实两种主要成分之间以及主要成分与赋形剂之间没有峰干扰。此外，与标准溶液相比，在20–120%的浓度范围内，其线性良好，相关系数为0.9999。所开发的同时定量分析缩短了西他列汀磷酸酯一水合物达格列嗪丙二醇一水合物FDC双层片的分析时间和高效性。通过准确度和精密度、检测和定量限以及溶液稳定性测试验证了分析方法的有效性。此外，还认为参照其他FDC双层片的同时定量分析方法开发分析方法是有益的。

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The development and validation of simultaneous quantitative analysis reversed-phase high-performance liquid chromatography for sitagliptin phosphate monohydrate and dapagliflozin propanediol monohydrate fixed-dose combination dual-layered tablet

Sitagliptin phosphate monohydrate-dapagliflozin propanediol hydrate fixeddose combination (FDC) dual-layered tablet is used for type 2 diabetes treatment. Simultaneous quantitative analysis can shorten the analysis time of sitagliptin phosphate monohydrate-dapagliflozin propanediol monohydrate FDC dual-layered tablets and increase their efficiency. This study aimed to develop the simultaneous quantitative analysis for sitagliptin phosphate monohydrate-dapagliflozin propanediol monohydrate FDC dual-layered tablet, a type 2 diabetes treatment. Simultaneous quantitative analysis using the rapid and selective reversed-phase highperformance liquid chromatography (RP-HPLC) method was developed and validated using method validation. RP-HPLC analysis was conducted using an ultraviolent absorption spectrophotometer and a Zorbax C18 column (4.6 x 150 mm, 5 µm). The flow rate and injection volume were set to 1.5 mL min-1 and 20 µL, respectively. The wavelength was set at 205 nm. The retention times of sitagliptin phosphate monohydrate and dapagliflozin propanediol monohydrate were 2.28 mins and 10.65 mins, respectively. The relative standard deviations of the system suitability for validation of simultaneous quantitative analysis were 0.03% for sitagliptin phosphate monohydrate and dapagliflozin propanediol monohydrate. The chromatogram confirmed that there was no peak interference between the two main components and between the main component and the excipients. In addition, It revealed a favorable linearity with correlation coefficients of 0.9999 in the concentration range of 20–120% compared to the standard solution. The developed simultaneous quantitative analysis shortened the analysis time and high efficiency of the sitagliptin phosphate monohydrate-dapagliflozin propanediol monohydrate FDC bilayer tablet. The validity of the analytical method was verified through accuracy and precision, detection and quantitation limits, and solution stability tests. In addition, it was thought that it would be helpful in developing an analytical method by referring to the simultaneous quantitative analysis method for developing other FDC dual-layered tablets.

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来源期刊

Current Pharmaceutical Analysis 医学-药学

CiteScore

1.50

自引率

0.00%

发文量

审稿时长

3 months

期刊介绍： Aims & Scope Current Pharmaceutical Analysis publishes expert reviews and original research articles on all the most recent advances in pharmaceutical and biomedical analysis. All aspects of the field are represented including drug analysis, analytical methodology and instrumentation. The journal is essential to all involved in pharmaceutical, biochemical and clinical analysis.