Sustainable HPLC technique for measurement of antidiabetic drugs: Appraisal of green and white metrics, content uniformity, and in vitro dissolution

被引:4
作者
Al-Wasidi, Asma S. [3 ]
Ahmed, Hoda A. [4 ]
Mahgoub, Samar M. [5 ]
Mohamed, Mahmoud A. [1 ]
Nassar, Hossam F. [2 ]
机构
[1] Hikma Pharmaceut Co, Bani Suwayf 62511, Egypt
[2] Beni Suef Univ, Fac Postgrad Studies Adv Sci, Environm Sci & Ind Dev Dept, Bani Suwayf 62511, Egypt
[3] Princess Nourah bint Abdulrahman Univ, Coll Sci, Dept Chem, POB 84428, Riyadh 11671, Saudi Arabia
[4] Cairo Univ, Dept Chem, Fac Sci, Giza 12613, Egypt
[5] Beni Suef Univ, Fac Postgrad Studies Adv Sci PSAS, Mat Sci & Nanotechnol Dept, Bani Suwayf 62511, Egypt
关键词
metformin; empagliflozin; green chemistry; white chemistry; in vitro dissolution study; RP-HPLC; 6; SIGMA; METFORMIN; QUALITY; TOOL;
D O I
10.1515/revac-2023-0075
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Green chemistry and white chemistry are two approaches to chemistry that prioritize sustainability and environmental protection. The pursuit of green chemistry is to develop chemical processes and products that decrease or stop the use and generation of dangerous materials. In contrast, white chemistry focuses on developing energy-efficient, sustainable chemical processes that produce minimal waste. Our study evaluated the environmental friendliness of the suggested approach, using eight greenness appraisal techniques, including analytical eco-scale, analytical method volume intensity, HPLC-environmental assessment tool, analytical method greenness score, analytical greenness, analytical greenness metric for sample preparation, green analytical procedure index, and complexgreen analytical procedure index, in addition to the unique metric blue applicability grade index of white chemistry. We have developed and validated a highly effective and reliable method for concurrently analyzing designated pharmaceutical medications characterized in metformin (MET) and empagliflozin (EMP) formulations, including their degraded products. This method is cost-effective, specific, and environmentally friendly, utilizing reversed-phase high-performance liquid chromatography with an XBridge BEH C8 column (150 mm x 4.6 mm, 5 mu m) at a flow rate of 1.0 mL<middle dot>min(-1), an injection volume of 5.0 mu L, a column oven temperature of 50 degrees C, a wavelength of 224 nm, and a mobile phase comprised of phosphate buffer adjusted at pH 6.8 and acetonitrile in gradient mode. In the HPLC method, linearity has been achieved over the concentration range of 10-106 and 30-1,050 mu g<middle dot>mL(-1) for EMP and MET, respectively, with correlation coefficients more than 0.999 and good recoveries within 98-102%. An assessment of the content uniformity of finished products confirmed that they met the declaration's acceptance standards (85-115%). A comparative study has been successfully conducted on generic and reference products, demonstrating their similarity. The suggested approach was validated by adhering to international council for harmonisation criteria.
引用
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页数:18
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