DEVELOPMENT AND VALIDATION OF A HPLC-DAD METHOD FOR DETERMINING THE PURITY OF ALLOPURINOL IMPURITY C
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Abstract
Background: Development and validation of a high performance liquid chromatography with diode-array detector method (HPLC-DAD) for determining the purity of allopurinol impurity C to achieve reliability, not be affected by the decomposition product. To our the best knowledge, this study is the first publication. That is an urgent need. Objectives: Development and validation of a high performance liquid chromatography with diode array detector method for determining the purity of allopurinol impurity C. Materials and method: Allopurinol impurity C; development and validation of a high performance liquid chromatography with diode-array detector method for determining the purity of allopurinol impurity C was according to the instructions of International Conference on Harmonization and Drug Registration Manual of Ministry of Health, Vietnam. Results: High performance liquid chromatography with diode array detector, reversed phase Phenomenex Synergi 4u MAX-RP 80R C12 column, mobile phase consisting of acetonitril: phosphoric acid pH=2.0 (adjusted with 10% H3PO4) (2:98), column temperature at 250C, flow rate 1mL/min, wavelength detection 200nm. The linear concentration range 50-190 µg/mL, the regression equation for allopurinol impurity C was y=324681x with R2 0.9966, p<0.005. The method showed that there was linearity in the range of investigated concentrations, achieving intermediate precision, accuracy, specificity, the limit of detection was 0.25µg/mL, and the limit of quantitation was 0.75µg/mL. Conclusion: A reliable HPLC method was successfully validated, which can be applied to determine the purity of the synthesized allopurinol C impurity.
Keywords
allopurinol C impurity, HPLC
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