Gas Chromatographic Determination of Residual Solvents in Pharmaceutical Excipients

S. B. Puranik, Varun R. Pawar, N. Lalitha, P. N. Sanjay Pai, G. K. Rao

Abstract: A systematic approach for the identification and quantification of organic volatile impurities (OVIs) in pharmaceutical excipients was described in the proposed Analytical method was developed utilizing capillary gas chromatography with flame ionization detector and validated as per ICH guidelines for residual solvent analysis in different pharmaceutical excipients. The separation was carried out on BP 624 column (30m X 0.53mm i.d. X 0.25m coating thickness), using GC 17 A shimadzu, with nitrogen as carrier gas in the split mode by direct injection method. The method described was simple, sensitive, rugged, reliable and reproducible for the quantitation of organic volatile impurities (OVIs) at residual levels as per ICH guidelines from pharmaceutical excipients.
There is a growing appreciation of the role that pharmaceutical excipients play in enhancing stability, bioavailability, and delivery of active drugs. Purity of excipients is becoming increasingly important in the development and manufacture of pharmaceutical products as the quality of excipients can have a significant impact on the safety and efficacy of drug products.

Organic solvents, which are widely used in the production of excipients for synthesis and purification, may not be completely removed by practical manufacturing techniques. The residue of these solvents offers no therapeutic benefit, but can present a serious potential hazard to human health. Therefore, it is essential to ensure that the residual solvents, (organic volatile impurities (OVIs)) should be below the acceptable levels stipulated in worldwide regulatory standards, such as ICH3 and USP4. The use of some highly toxic/carcinogenic solvents has to be controlled to extremely low levels and demands extremely sensitive detection methods. Analysis of OVIs is known to be one of the most challenging analytical tasks in pharmaceutical analysis and control. Excipients present an even greater challenge due to the fact that information regarding the presence of OVIs in excipients may be difficult to obtain from a supplier who is unwilling to provide comprehensive data on the materials because of fear that the information could be exploited by a competitor. Unknown OVIs are often detected during the routine quality control testing of OVIs in excipients using official methods, resulting in lengthy laboratory investigations which can cause costly delays in manufacturing. Hence, the situation necessitates the development of a rapid, sensitive, and reliable analytical method to screen, identify, and quantitate any OVIs in pharmaceutical excipients.


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