Method development and validation for analysis of residual solvents in budesonide by hs-gc

Residual solvents are organic volatile impurities which are harmful to environment as well as human health. The analysis of such solvents is an important part in maintaining the quality of drug. A number of analytical methods are available for such analysis but most of them are restricted to low detection limits or lack of accuracy. Gas chromatography is one of the widely used method for such analysis due to more accuracy and high detection limits. The present study is focused on the analysis of residual solvents in Budesonide drug by HS-GS Chromatography by development and validation of a suitable method. The residual solvents methanol, acetone, methylene chloride, di-isopropyl ether and butraldehyde were determined. Based upon analytical data and result of each study it is concluded that the method is specific, precise, accurate, linear, robust and rugged with established limit of detection and limit of quantitation. The % RSD of 50 % level of all above solvents are 93.57, 91.07, 91.64, 102.11 and 93.07. The percentage recovery for all above solvents are between 80% and 120%, which is well within the acceptance criteria. Hence, accuracy by recovery for the solvents was established. The relative standard deviation between results of sample obtained with changed condition and that under normal experimental condition is within the acceptance criteria.