Quantification of Cyclophosphamide Impurities in Cyclophosphamide Drug Substance and formulations by Ion chromatography

Non suppressed Ion chromatographic method for quantification of Cyclophosphamide Impurities A, B, D and Propanolamine was optimized validated. In this method, low capacity cation exchange column was used with low strength acidic mobile phase to achieve the optimum resolution between all the impurities which further detected on Conductivity and UV detectors, which were connected in series. Additionally, propanolamine impurity was also quantified in same method simultaneously. LOQ was established at 10 mg/L for Impurity A, B and D while for propanolamine it is 2 .0 mg/L. Also, method found to be linear with correlation coefficient of 0.999 for each impurity. Also, Accuracy results for all the impurities observed between 90 to 110 %. The method validation results showed the perfect precision, accuracy and linearity of the method. Also, same method used to quantify the cyclophosphamide impurities in Cyclophosphamide containing formulations like Sterile powder for Injection and Capsules. Hence the method can be recommended as an alternative for compendial TLC method for simultaneous determination of these Cyclophosphamide Impurities.