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2. The content of the residual solvent dioxane impurity in the drug gramadol (tramadol hydrochloride) substance (crystalline powder) is determined by GLC using chromatograms of the analyzed and standard solutions.
To prepare the solution to be analyzed, add m = 200 mg of the drug to a 10 ml volumetric flask, add a small amount of water in which the drug is dissolved, adjust the volume of the solution in the flask to the mark with water and mix. The test solution is obtained.
To prepare a standard solution of dioxane, add m1 = 10 mg of dioxane to a 250 ml volumetric flask, add a small amount of water until the dioxane dissolves, adjust the volume of the solution in the flask to the mark with water, mix and obtain a standard solution.
On a gas-liquid chromatograph, chromatograms of the analyzed and standard solutions are recorded (dose of 2 μl) and the peak areas of the analyzed S and standard S(ct) solutions are measured. Derive a formula to calculate the percentage of W dioxane in the original drug tramadol.
Calculate the percentage of dioxane in the analyzed drug if the ratio of peak areas in the chromatograms is found to be S/S(cm) = 0.98.
If the file does not open for you, install the Rar archiver program. Inside the archive, the solution is in WORD format.
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