Determination of Irinotecan enantiomer impurity in Irinotecan Hydrochloride API by using reverse-phase liquid chromatography

To evaluate and quantify Irinotecan (R-enantiomer) / related compound D in hydrochloride trihydrate API, a high stereo-specific liquid chromatography technique was developed validated. The partition accomplished on ChiralpakIC-3 (150 x 4.6 mm 3µm) through mobile fragment comprising 0.1 % v/v Formic acid water acetonitrile with 1mL/min, 250C, 20µL, 50C 370 nmas flow rate, column temparture, injection volume, sample cooler temperature detection wavelength. At 8.903 9.75 min, the retention time of (S-enantiomer) determined. resolution between found to be 2.4. impurity acceptance limit is 0.2 %. established method's precision, accuracy, sensitivity, linearity, specificity, ruggedness were all verified accordance ICH recommendations. qualifying LOQ 0.4 g/ml, while minimal amount needed for LOD 0.12 g/ml. proposed reversed-phase method has been sophisticated authenticated criteria capable quantifying irinotecan enantiomer API at trace level concentration. accuracy approach used guarantee its efficacy; as result, it appropriate task hand, may successfully routine laboratory analysis, can utilised quality control.
 Keywords: Irinotecan, technique,