DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR AZATHIOPRINE IN PHARMACEUTICAL DOSAGE FORM.
Mehta Hiralben Satishchandra*, Dr. Indrajeet Singhvi and Dr. Hasumati Raj
ABSTRACT
The method developed used for assay of azathioprine in pharmaceutical dosage form. A simple, rapid and reproducible high performance reverse phase liquid chromatographic method has been developed for quantitative estimation of Azathioprine in tablets form using a, Phenomenex 250 mm x 4.9 mm C18, 5 um, inertsil and UV detection at 240nm. The isocratic elution was used to quantify the analyte and the mobile phase was acetate buffer: Acetonitrile (30: 70) was pumped at 1.0 ml/min. The method was linear between 50-300 μg/ml, statistically validated for its linearity, precision and accuracy. The intra-and - inter day variation was found to be less than 1% showing high precision of the assay method. The method is selective and sensitive which can be used for the estimation of azathioprine in presence of excipients.
Keywords: HPLC, Azathioprine Validation ICH guidelines.
[Full Text Article]
[Download Certificate]