Residual solvents determination in drug products by static headspace-gas chromatography |
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Authors: | C C Camarasu |
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Institution: | 1.Central Analytical Laboratory,Gedeon Richter Ltd,Budapest,Hungary |
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Abstract: | Summary Two static headspace selective methods for residual solvents belonging to Class I, II and III have been developed, optimized
and validated for drug products, which are insoluble in water.
The methods give very good sensitivities (detection limits under 10 ppm) and precision (under 5.5% RSD) for all solvents.
The detection limit for benzene was 0.1 ppm, in concordance with Pharmacopoeia requirements. During method optimization we
found that sample volume and water content have a critical influence on the sensitivity. From our data, it is beneficial to
choose low sample volume. If sample solubility in the organic solvent allows it, the optimum sample volume is between 0.1
and 0.3 mL. For drug products with water content greater than 7%, the increase in sensitivity produced by water presence should
be taken into consideration, otherwise inconsistent recovery data and underestimation of residual solvent content will happen.
The headspace vial volume has a critical influence on system precision.
Presented at Balaton Symposium '01 on High-Performance Separation Methods, Siófok, Hungary, September 2–4, 2001 |
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Keywords: | Gas chromatography Static headspace analysis Residual solvents in drugs Method development and optimization Method validation |
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