Main goal of this research is to develop and validate a simple, specific, precise, and sensitive Reverse phase Ultra Performance Liquid Chromatography (RP-UPLC) method for the quantitative determination of Umbralisib in bulk and pharmaceutical dosage form that is also cost effective and rapid. A UV detector with a detection wavelength of 219 nm was used to observe the wavelength of the analyte during its elution on Kinetex column of dimensions 100 × 4.6 mm, 2.6 μm with a moving phase composed of 0.1% formic acid: acetonitrile (40:60 v/v) delivered at a stream of 1.0 ml/minute. The linearity of this method was demonstrated for Umbralisib over a concentration range of 230 μg/ ml, with a correlation coefficient of 0.999. Using a 3-minute run time, it was discovered that Umbralisib retention time was 1.554 minutes. The results of the validation were in excellent agreement with the acceptable limits. Statistically significant differences Relative standard deviation (RSD) of less than 2.0% indicate that this method is accurate and precise. The proposed method was, therefore, deemed to be suitable for the regular analysis and quality control of pharmaceutical preparations containing active drug, as demonstrated by the results of the experiment.
Key words: RP-UPLC, Umbralisib, Development, Validation
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