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Development and Validation of an Automated Gas Chromatography Method for Determination of Dichloromethane in Ampicillin Sodium by Using Capillary Column Technology



The main aim of the study was to develop an automated static headspace gas
chromatography (SHS-GC) method for determination of dichloromethane (DCM) in ampicillin sodium
by using a capillary column.



SHS-GC also known as gas chromatography-headspace is the technique of choice due to its
high sensitivity, excellent separation abilities, low limit of detection and simplicity of the instrumentation
used for the technique. The headspace sampling method has more appropriate sensitivity than the
direct injection method because it can clearly separate volatile analytes from the sample matrix and
effectively concentrate them. Therefore, this method results in less complex sample preparation, decreased
instrument contamination, and increased capillary column life.



The developed SHS-GC method showed symmetrical peak shape reasonable retention time for
DCM. A linear relationship was obtained over the range of 2-240 μg mL-1 with a correlation coefficient
(r2) of 0.993. The recovery, system precision and robustness of the method were within the acceptable
values. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were 0.5 μg mL-1 and 2 μg mL-1
respectively.



The results obtained in this study demonstrate that SHS-GC method is selective, precise,
linear, accurate and robust for determination of dichloromethane in ampicillin sodium and its formulation
(injection).
