Menda Jyothsna, Chintala Vaishnavi, Kanuparthy Phani Raja, Katari Naresh Kumar, Kowtharapu Leela Prasad, Jonnalagadda Sreekantha Babu
Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telangana 502329, India.
Department of Chemistry, Gokaraju Lailavathi Womens Engineering College, Hyderabad 500090, India.
ACS Omega. 2024 Mar 7;9(11):12553-12563. doi: 10.1021/acsomega.3c04589. eCollection 2024 Mar 19.
The UPLC methodology was used to establish a method for determining the qualitative and quantitative content of teneligliptin and remogliflozin tablets in oral solid dose form, as no simultaneous method was available. The developed liquid chromatography method consists of an X-Bridge C18 100 mm × 3.5 mm, 2.1 mm column with an economical 0.2 mL/min flow rate. A wavelength of 248 nm was used for detection, and the temperature of the column compartment was 30 °C. The method was evaluated using a static tool quality by design after it was validated as per the regulations. The data from validation result in linearity for both analytes with a correlation coefficient of more than 0.999. The accuracy data were found from a minimum of 98.1 to a maximum of 100.9. All of the validation results met the acceptance criteria. The stability of the analytical solutions proved for 24 h at bench and refrigerator temperatures. Studies of force degradation proved the stability indicating the nature of the method. A factorial design was used to evaluate the method performance.
由于没有同时测定替格列汀和瑞格列净片口服固体制剂中定性和定量含量的方法，因此采用超高效液相色谱（UPLC）方法建立了一种测定方法。所开发的液相色谱方法采用X-Bridge C18 100 mm×3.5 mm、2.1 mm柱，流速为经济的0.2 mL/min。检测波长为248 nm，柱温箱温度为30℃。该方法在按照规定进行验证后，使用设计质量静态工具进行评估。验证数据表明两种分析物均具有线性，相关系数大于0.999。准确度数据最低为98.1，最高为100.9。所有验证结果均符合验收标准。分析溶液在室温及冷藏温度下24小时内稳定性良好。强制降解研究证明了该方法的稳定性指示性质。采用析因设计评估方法性能。
