Review of the article „Simultaneous determination of cholecalciferol and 25-hydroxycholecalciferol in lipid-based self nanoemulsifying formulations and marketed product VI-DE 3® by UHPLC-UV“, verified by Publons, Web of Science
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Abstract:
Purpose: The purpose of the current study was to develop a selective, precise, fast and economical reverse phase ultra-high-performance liquid chromatography (UHPLC UV) advanced method and validate for the simultaneous estimation of cholecalciferol and its analogue 25- ydroxycholecalciferol in lipid-based self-nanoemulsifying formulation (SNEDDS).
Method: The chromatographic separation was simply performed on a Dionex ® UHPLC systems
(Ultimate 3000, Thermo scientific) by using HSS C18 (2.1x50 mm, 1.8μm) analytical column.
The UV detection was carried out isocratically with the mobile phase consisting of acetonitrile
and methanol in the ratio of (50:50 %v/v) with a flow rate of 0.4 ml/min at 265nm. The injection
volume was 1μl and the column temperature was maintained at 45°C. FDA regulatory guidelines
were used to develop and validate the method. Results: The current developed UHPLC-UV
method was found to be rapid (run time 2 min), and selective with high resolution o...f
cholecalciferol and 25-hydroxycholecalciferol (RT=0.530 min & 1.360 min) from different lipid
matrices. The method was highly sensitive (Limit of Detection and Lower Limit of
Quantification were 0.13ppm & 0.51ppm, and 0.15ppm & 0.54ppm, respectively). The linearity,
accuracy and precision were determined as suitable over the concentration range of 0.5-50.0 ppm for both the analytes. Conclusion: The proposed UHPLC-UV method can be used for the
determination of cholecalciferol and 25-hydroxycholecalciferol in SNEDDS and marketed Vi-De
as pure forms (intact) with no interference of excipients or drug related substances.
Извор:
Current Pharmaceutical Analysis, 2019, 1/BMS-CPA-2019-47-28Колекције
Институција/група
Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2019 UR - https://machinery.mas.bg.ac.rs/handle/123456789/5897 AB - Abstract: Purpose: The purpose of the current study was to develop a selective, precise, fast and economical reverse phase ultra-high-performance liquid chromatography (UHPLC UV) advanced method and validate for the simultaneous estimation of cholecalciferol and its analogue 25- ydroxycholecalciferol in lipid-based self-nanoemulsifying formulation (SNEDDS). Method: The chromatographic separation was simply performed on a Dionex ® UHPLC systems (Ultimate 3000, Thermo scientific) by using HSS C18 (2.1x50 mm, 1.8μm) analytical column. The UV detection was carried out isocratically with the mobile phase consisting of acetonitrile and methanol in the ratio of (50:50 %v/v) with a flow rate of 0.4 ml/min at 265nm. The injection volume was 1μl and the column temperature was maintained at 45°C. FDA regulatory guidelines were used to develop and validate the method. Results: The current developed UHPLC-UV method was found to be rapid (run time 2 min), and selective with high resolution of cholecalciferol and 25-hydroxycholecalciferol (RT=0.530 min & 1.360 min) from different lipid matrices. The method was highly sensitive (Limit of Detection and Lower Limit of Quantification were 0.13ppm & 0.51ppm, and 0.15ppm & 0.54ppm, respectively). The linearity, accuracy and precision were determined as suitable over the concentration range of 0.5-50.0 ppm for both the analytes. Conclusion: The proposed UHPLC-UV method can be used for the determination of cholecalciferol and 25-hydroxycholecalciferol in SNEDDS and marketed Vi-De as pure forms (intact) with no interference of excipients or drug related substances. T2 - Current Pharmaceutical Analysis T1 - Review of the article „Simultaneous determination of cholecalciferol and 25-hydroxycholecalciferol in lipid-based self nanoemulsifying formulations and marketed product VI-DE 3® by UHPLC-UV“, verified by Publons, Web of Science EP - 28 SP - 1/BMS-CPA-2019-47 UR - https://hdl.handle.net/21.15107/rcub_machinery_5897 ER -
@article{ author = "Jovanović, Tamara", year = "2019", abstract = "Abstract: Purpose: The purpose of the current study was to develop a selective, precise, fast and economical reverse phase ultra-high-performance liquid chromatography (UHPLC UV) advanced method and validate for the simultaneous estimation of cholecalciferol and its analogue 25- ydroxycholecalciferol in lipid-based self-nanoemulsifying formulation (SNEDDS). Method: The chromatographic separation was simply performed on a Dionex ® UHPLC systems (Ultimate 3000, Thermo scientific) by using HSS C18 (2.1x50 mm, 1.8μm) analytical column. The UV detection was carried out isocratically with the mobile phase consisting of acetonitrile and methanol in the ratio of (50:50 %v/v) with a flow rate of 0.4 ml/min at 265nm. The injection volume was 1μl and the column temperature was maintained at 45°C. FDA regulatory guidelines were used to develop and validate the method. Results: The current developed UHPLC-UV method was found to be rapid (run time 2 min), and selective with high resolution of cholecalciferol and 25-hydroxycholecalciferol (RT=0.530 min & 1.360 min) from different lipid matrices. The method was highly sensitive (Limit of Detection and Lower Limit of Quantification were 0.13ppm & 0.51ppm, and 0.15ppm & 0.54ppm, respectively). The linearity, accuracy and precision were determined as suitable over the concentration range of 0.5-50.0 ppm for both the analytes. Conclusion: The proposed UHPLC-UV method can be used for the determination of cholecalciferol and 25-hydroxycholecalciferol in SNEDDS and marketed Vi-De as pure forms (intact) with no interference of excipients or drug related substances.", journal = "Current Pharmaceutical Analysis", title = "Review of the article „Simultaneous determination of cholecalciferol and 25-hydroxycholecalciferol in lipid-based self nanoemulsifying formulations and marketed product VI-DE 3® by UHPLC-UV“, verified by Publons, Web of Science", pages = "28-1/BMS-CPA-2019-47", url = "https://hdl.handle.net/21.15107/rcub_machinery_5897" }
Jovanović, T.. (2019). Review of the article „Simultaneous determination of cholecalciferol and 25-hydroxycholecalciferol in lipid-based self nanoemulsifying formulations and marketed product VI-DE 3® by UHPLC-UV“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2019-47-28. https://hdl.handle.net/21.15107/rcub_machinery_5897
Jovanović T. Review of the article „Simultaneous determination of cholecalciferol and 25-hydroxycholecalciferol in lipid-based self nanoemulsifying formulations and marketed product VI-DE 3® by UHPLC-UV“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2019;:1/BMS-CPA-2019-47-28. https://hdl.handle.net/21.15107/rcub_machinery_5897 .
Jovanović, Tamara, "Review of the article „Simultaneous determination of cholecalciferol and 25-hydroxycholecalciferol in lipid-based self nanoemulsifying formulations and marketed product VI-DE 3® by UHPLC-UV“, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2019):1/BMS-CPA-2019-47-28, https://hdl.handle.net/21.15107/rcub_machinery_5897 .