Dapagliflozin is a novel sodium-glucose cotransporter type 2 inhibitor. This work aims to develop a new
validated sensitive RP-HPLC coupled with a mass detector method for the determination of dapagliflozin, its
alpha isomer, and starting material in the presence of dapagliflozin major degradation products and an internal
standard (empagliflozin). The separation was achieved on BDS Hypersil column (length of 250mm, internal
diameter of 4.6 mm and 5-μm particle size) at a temperature of 35℃. Water and acetonitrile were used as
mobile phase A and B by gradient mode at a flow rate of 1 mL/min. A wavelength of 224nm was selected to
perform detection using a photo diode array detector. The method met the requirement of the International
Conference on Harmonisation for Registration of Pharmaceuticals for Human Use (ICH) for validation. The
molecular weight of impurities and degradation products was estimated using positive ESI-MS. Fifteen
impurities were detected during the analysis of dapagliflozin APIs and the brand Farxiga ® and some generic
products. Three of fifteen detected impurities (H, J and K) exceeded the impurities acceptable limits 0.1%.
Those impurities were isolated using new preparative chromatography then characterized using elemental
analysis, FTIR and NMR.
This paper is an applied study of the temporal meaning of structure, to assess the strength of time-dependent expressions as a framework for the action or verb
Due to the developments taking place in the field of communications, informatics systems and knowledge management in the current century, and the obligations and burdens imposed on the business organization to keep pace with these developments, the traditional methods of administrative decision-making are no longer feasible, as recent trends have emerged in management that focus on the need to rely on quantitative methods such as operations research.. The latter is one of the results of World War II, which appeared for the first time in Britain to manage war operations. The first method used in this field is the linear programming method. The use of operations research has developed greatly in the past years, and the methods of analysis in
... Show MoreA spectrophotometric method has been proposed for the determination of two drugs containing phenol group [phenylephrine hydrochloride (PHP) and salbutamol sulphate (SLB)] in pharmaceutical dosage forms. The method is based on the diazotization reaction of metoclopramide hydrochloride (MCP) and coupling of the diazotized reagent with drugs in alkaline medium to give intense orange colored product (?max at 470 nm for each of PHP and SLB). Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. Under the proposed optimum condition, Beer’s law was obeyed in the concentration range of 1-32 and 1-14 ?g mL-1 for PHP and SLB, respectively. The limit of detection (LOD) and l
... Show MoreThe Reversed Phase High Performance Liquid Chromatography (RP-HPLC) has been used for the separation of Poly aromatic hydrocarbons(PAHs) by using column Reprosil 100 C 18 which was found to be a suitable one for this purpose. The result showed that using mobile phase of (Acetonitrile-water) Reversed Phase HPLC , flow rate of (1.2 ml/min) , column temperature (30CËš) and wave length of (254nm), give a complete separation with a good resolution . The total separation time was less than 20 min. The result of the study showed that the vegetables of Baghdad city were polluted by poly aromatic hydrocarbons(PAHs) in different places where samples taken because of drainage of the heavy water ,industrial trash and trash of oil colanders. -
... Show MoreNew, simple and sensitive batch and Flow-injecton spectrophotometric methods for the determination of Thymol in pure form and in mouth wash preparations have been proposed in this study. These methods were based on a diazotization and coupling reaction between Thymol and diazotized procaine HCl in alkaline medium to form an intense orange-red water-soluble dye that is stable and has a maximum absorption at 474 nm. A graphs of absorbance versus concentration show that Beer’s law is obeyed over the concentration range of 0.4-4.8 and 4-80 µg.ml-1 of Thymol, with detection limits of 0.072 and 1.807 µg.ml-1 of Thymol for batch and FIA methods respectively. The FIA procedure sample throughput was 80 h-1. All different chemical and physical e
... Show MoreSimple, precise and economic batch and flow injection analysis (FIA)-spectrophotometric methods have been established for simultaneous determination of salbutamol sulfate (SLB) in bulk powder and pharmaceutical forms. Both methods based on diazotization coupling reaction of SLB with another drug compound (sulfadimidine) as a safe and green diazotization agent in alkaline medium. At 444 nm, the maximum absorption of the orange azo-dye product was observed. A thorough investigation of all chemical and physical factors was conducted for batch and FIA procedures to achieve high sensitivity. Under the optimized experimental variables, SLB obeys Beer’s law in the concentration range of 0.25-4 and 10-100 μg/mL with limits of detection of 0.0
... Show MoreSimple, precise and economic batch and flow injection analysis (FIA)-spectrophotometric methods have been established for simultaneous determination of salbutamol sulfate (SLB) in bulk powder and pharmaceutical forms. Both methods based on diazotization coupling reaction of SLB with another drug compound (sulfadimidine) as a safe and green diazotization agent in alkaline medium. At 444 nm, the maximum absorption of the orange azo-dye product was observed. A thorough investigation of all chemical and physical factors was conducted for batch and FIA procedures to achieve high sensitivity. Under the optimized experimental variables, SLB obeys Beer’s law in the concentration range of 0.25-4 and 10-100 μg/mL with limits of detection o
... Show MoreAbstract: Background: Optical biosensors offer excellent properties and methods for detecting bacteria when compared to traditional analytical techniques. It allows direct detection of many biological and chemical materials. Bacteria are found in the human body naturally non-pathogenic and pathologically, as they are found in other living organisms. One of these bacteria is Escherichia coli (E. coli) which are found in the human body in its natural and pathogenic form. E.coli bacteria cause many diseases, including Stomach, intestines, urinary system infections, and others. The aim of this study: is sensing and differentiation between normal flora and pathogenic E.coli. Material and method:
... Show MoreSimplification of new fashion design methods
The research aims at integrating the disclosure of the business models with the qualitative characteristics of accounting information. To achieve this, the elements of the business model should be identified and disclosed, and then study the possibility of integrating the disclosure of the business model with the qualitative characteristics of accounting information.
To achieve this objective, the research was based on the indicators of disclosure of the business model of the International Accounting Standards Board to measure the disclosure of the business model.
The research reached a number of conclusions, the most important of which were as follows:
Fi
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