Quality control methods for
Determination by gas chromatography
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Determination by gas chromatography
Perform the determination as described in Volume 1 of The international pharmacopoeia (5). Apparatus The equipment consists of: - a glass column 1.2 m long, internal diameter 2 mm; - a suitable stationary liquid phase; - a suitable diatomaceous support. Use nitrogen R as the carrier gas with a flow rate of 30.0 ml/min. The sample injection block should be maintained at 230°C, the column at 190°C and the detector, which should be nitrogen-selective, at 300°C. In addition: - volume of sample solution to be injected: 2.0 µl; - separation characteristics: h ≤ 1.2 x 10 -3 for desmetryn R; R S ≥ 1.2 for prometryn R and simazine R; - relative standard deviation (precision of chromatographic system): s r ≤ 0.05 for desmetryn R, prometryn R and simazine R. Method Chromatogram T. To determine the separation characteristics, inject solution S 2 (for the preparation of solution S 2 see "Determination of the rate of recovery" above). Chromatograms A 1 -A 5 . To determine the relative standard deviation, inject solution S 2 and repeat the determination 5 times. Quality control methods for medicinal plant materials Chromatogram S 2 . Inject 1.0 ml of solution S 2 for the determination of the rate of recovery. Dilute 1.0 ml of solution S 2 to 10.0 ml with acetone R and inject it for the chromatographic determination. On the chromatogram the peaks occur in the following sequence: prometryn, simazine, desmetryn. Chromatogram P 2 . Inject the purified extract or the especially purified extract. Determine using an external standard: a = 0.0005To convert the values obtained to percentage by weight, multiply the concentration in mg/kg by 10 4 . The total maximum permissible amount of residues due to desmetryn, prometryn and simazine is 2 mg per kg of plant material. |
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