Development and validation of liquid chromatographic method for aripiperazole

A simple isocratic, rapid and sensitive high performance liquid chromatographic method has been developed for quantitative determination of Aripiperazole and its four process related impurities. The method has been validated for determination of related substance in aripiperazole using C8 ODS (150X4.6mm) column by keeping the flow rate of 1ml/min and having sensitivity of 0.5.The elution is carried out by using mobile phase of 500ml aq.buffer(0.2%TFA),400ml acetonitrile and 100 ml methanol. pH is adjusted to 3 bt TEA. The detection is carried out at 254nm with injection volume of 10 microlitre. Specificity, system suitability, linearity, precision, ruggedness, robustness has been carried out for aripiperazole. Limit of quantification and limit of detection has been carried out for the impurities of aripiperazole. Forced degradation study of aripiperazole has been carried out .Impurity profiling is also been carried out.

Author(s): Nandini R. Pai and Deeptaunshu Atul Pusalkar

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