本研究比较了超高效液相色谱(UHPLC)和紫外-可见分光光度法对五种市售盐酸二甲双胍产品中盐酸二甲双胍的定量性能。在UHPLC中测量盐酸二甲双胍,流动相由0.05M磷酸盐缓冲溶液和pH为3.6的甲醇(35:65,v/v)的混合物组成。使用甲醇和水的混合物作为空白,在234nm下分光光度法测定盐酸二甲双胍。在两种技术中,盐酸二甲双胍的方法线性在(2.5-40μg/ml)的浓度范围内。验证过程包括特异性评估,选择性,线性度准确度,精度,定量下限(LLOQ),检测下限(LLOD),鲁棒性,和系统适用性。对于UHPLC验证方法,重复性和再现性(以相对标准偏差表示)分别小于1.578和2.718%,分别。盐酸二甲双胍的LLOQ为0.625μg/ml,LLOD为0.156μg/ml。对于紫外-可见分光光度验证方法,重复性和再现性(表示为相对标准偏差)小于3.773和1.988%,分别。UHPLC和UV-Vis分光光度法对五种品牌盐酸二甲双胍片的回收率分别为(98-101%)和(92-104%),分别。总之,上述方法已成功用于不同药物片剂中盐酸二甲双胍的定量分析。
The present study compared the performance of Ultra-high performance liquid chromatography (
UHPLC) and UV-Vis spectrophotometry for the quantification of metformin hydrochloride in five commercially available metformin hydrochloride products with different strengths. The metformin hydrochloride was measured in the
UHPLC with a mobile phase consisting of a mixture of 0.05 M phosphate buffer solution and methanol (35:65, v/v) with a pH of 3.6. Metformin hydrochloride was determined spectrophotometrically at 234 nm using a mixture of methanol and water as a blank. The methods\' linearity for metformin hydrochloride was within the concentration range of (2.5-40 μg/ml) in both techniques. The validation process encompassed assessments of specificity, selectivity, linearity, accuracy, precision, the lower limit of quantification (LLOQ), the lower limit of detection (LLOD), robustness, and system suitability. For the
UHPLC validation method, the repeatability and reproducibility (expressed as relative standard deviation) were less than 1.578 and 2.718 %, respectively. The LLOQ for metformin hydrochloride was 0.625 μg/ml, and the LLOD was 0.156 μg/ml. For the UV-Vis spectrophotometric validation method, the repeatability and reproducibility (stated as relative standard deviation) were less than 3.773 and 1.988 %, respectively. The percentage recovery results for the five brands of metformin hydrochloride tablets were (98-101 %) and (92-104 %) for the
UHPLC and UV-Vis spectrophotometric methods, respectively. In conclusion, the described methodologies were successfully employed for the quantitative analysis of metformin hydrochloride in different pharmaceutical tablet products.