Abstract
Abstract A rapid, specific, sensitive, and precise reverse-phase UPLC method was developed for the quantitative determination of a typical anticancer drug. Olaparib and its eight potential impurities in drug substances is described in this report. Statistical experimental designs (DOE) are used as advancement over conventional experimental approach .It provides more accurate results in fewer runs compared with conventional methods. Chromatographic separation was achieved on a Waters Acquity UPLC® BEH C18 (2.1 mm × 100 mm, 1.7 micron) column, using buffer (1.0ml Orthophosphoric acid in 1000ml water) and acetonitrile in gradient elution mode. The flow rate was kept at 0.4mL/min; thermostated at 35˚C with a short runtime of 15 min. The optimized method was found to produce symmetric and sharp peaks with good separation between processes related impurities and degradation impurities. Quantification is achieved with photodiode array detection at 220 nm over the concentration range of 10- 20 μg/mL. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating capability of the developed UPLC method. Developed method is validated as per ICH guidelines and found to be linear, accurate, specific, selective, precise and robust. The method is useful during process development and quality of bulk manufacturing.
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