Present study was aimed to develop and validate a reverse-phase high-performance liquid chromatography method for simultaneous determination of sitagliptin phosphate and metformin hy-drochloride in a marketed formulat...Present study was aimed to develop and validate a reverse-phase high-performance liquid chromatography method for simultaneous determination of sitagliptin phosphate and metformin hy-drochloride in a marketed formulation. The drug separation was performed on Hibar-240, Li-chrosphere-100 C18 ODS (250 × 4.6 mm, 5 μm) column, at a flow rate of 1 mL/min. The mobile phase used was a mixture of methanol: potassium di-hydrogen phosphate buffer at a ratio of 70:30 v/v. The detection was carried out at a wavelength of 266 nm. The retention times of sitagliptin phosphate and metformin hydrochloride were found as 6.1 and 4.9 min respectively. Linear calibration curves with good correlation coefficients were obtained over the concentration ranges of 10 - 50 μg/mL for sitagliptin and 20 - 100 μg/mL for metformin. The limit of detection was 0.016 and 0.14 μg/mL and the limit of quantification was 0.048 and 0.42 μg/mL for sitagliptin phosphate and metformin hydrochloride respectively. Validation of the method demonstrated system selectivity, specificity, linearity, accuracy and precision. The developed method was found useful in the simultaneous analysis of sitagliptin phosphate and metformin hydrochloride in formulation.展开更多
目的探讨磷酸西格列汀联合二甲双胍治疗初发2型糖尿病的临床效果。方法选取2016年8月至2018年2月本院收治的90例初发2型糖尿病患者,根据随机数字表法进行分组。对照组给予磷酸西格列汀治疗,观察组给予磷酸西格列汀联合二甲双胍治疗。比...目的探讨磷酸西格列汀联合二甲双胍治疗初发2型糖尿病的临床效果。方法选取2016年8月至2018年2月本院收治的90例初发2型糖尿病患者,根据随机数字表法进行分组。对照组给予磷酸西格列汀治疗,观察组给予磷酸西格列汀联合二甲双胍治疗。比较两组初发2型糖尿病治疗效果;血糖控制达标的平均时间;治疗前后患者FBG指标、2 h PBG指标、空腹胰岛素和体重指数;药物不良反应率。结果观察组初发2型糖尿病治疗效果高于对照组(P<0.05);观察组血糖控制达标的平均时间优于对照组(P<0.05);治疗前,两组FBG指标、2 hPBG指标、空腹胰岛素和体重指数比较差异无统计学意义;治疗后观察组FBG指标、2 h PBG指标、空腹胰岛素和体重指数优于对照组(P<0.05)。两组药物不良反应率比较差异无统计学意义。结论磷酸西格列汀联合二甲双胍治疗初发2型糖尿病的应用效果确切,可显著改善血糖和胰岛素,控制体质量,且无严重不良反应,安全有效,值得推广应用。展开更多
文摘Present study was aimed to develop and validate a reverse-phase high-performance liquid chromatography method for simultaneous determination of sitagliptin phosphate and metformin hy-drochloride in a marketed formulation. The drug separation was performed on Hibar-240, Li-chrosphere-100 C18 ODS (250 × 4.6 mm, 5 μm) column, at a flow rate of 1 mL/min. The mobile phase used was a mixture of methanol: potassium di-hydrogen phosphate buffer at a ratio of 70:30 v/v. The detection was carried out at a wavelength of 266 nm. The retention times of sitagliptin phosphate and metformin hydrochloride were found as 6.1 and 4.9 min respectively. Linear calibration curves with good correlation coefficients were obtained over the concentration ranges of 10 - 50 μg/mL for sitagliptin and 20 - 100 μg/mL for metformin. The limit of detection was 0.016 and 0.14 μg/mL and the limit of quantification was 0.048 and 0.42 μg/mL for sitagliptin phosphate and metformin hydrochloride respectively. Validation of the method demonstrated system selectivity, specificity, linearity, accuracy and precision. The developed method was found useful in the simultaneous analysis of sitagliptin phosphate and metformin hydrochloride in formulation.
文摘目的探讨磷酸西格列汀联合二甲双胍治疗初发2型糖尿病的临床效果。方法选取2016年8月至2018年2月本院收治的90例初发2型糖尿病患者,根据随机数字表法进行分组。对照组给予磷酸西格列汀治疗,观察组给予磷酸西格列汀联合二甲双胍治疗。比较两组初发2型糖尿病治疗效果;血糖控制达标的平均时间;治疗前后患者FBG指标、2 h PBG指标、空腹胰岛素和体重指数;药物不良反应率。结果观察组初发2型糖尿病治疗效果高于对照组(P<0.05);观察组血糖控制达标的平均时间优于对照组(P<0.05);治疗前,两组FBG指标、2 hPBG指标、空腹胰岛素和体重指数比较差异无统计学意义;治疗后观察组FBG指标、2 h PBG指标、空腹胰岛素和体重指数优于对照组(P<0.05)。两组药物不良反应率比较差异无统计学意义。结论磷酸西格列汀联合二甲双胍治疗初发2型糖尿病的应用效果确切,可显著改善血糖和胰岛素,控制体质量,且无严重不良反应,安全有效,值得推广应用。
