A gas chromatographic method has been developed for the determination of propionic acid in pramipexole hydrochloride drug substance. The method was optimised based on the basis of peak shape of propionic acid. The method was validated as per ICH guideline in terms of LOD, LOQ prediction, precision, accuracy, method precision, repeatability and specificity. The LOD and LOQ values were found to be 21 and 64 µg/g and linearity range was found to be 0.99875 and hence three commercial batches was analysed and propionic acid was not found in all three batches.
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