A New Stability Indicating Rp-Hplc Method Development And Validation For Estimation Of Baloxavir Marboxil In Pharmaceutical Dosage Form

Abstract

A simple, precise, accurate method was developed for the estimation of Baloxavir marboxil by RP-HPLC technique. Chromatographic conditions used are stationary KromasilC18 (150mm x 4.6 mm) ,5m , mobile phase 0.1%OPA: Methanol in the ratio of 50:50 and flow rate were maintained at 1.0ml/min, detection wave length was 220nm, column temperature was set to 30^oC and diluent was mobile phase conditions were finalized as optimized method. The retention time was found to be 2.199min. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R² value was found to be as 0.999. Precision was found to be 0.9 for repeatability 0.8 and 0.2 for intermediate precision. LOD and LOQ are 0.08µg/ml and 0.25µg/ml respectively. By using above method , assay of marketed formulation was carried out and 99.69% was present.  Degradation studies of Baloxavir marboxil were done in all conditions. Purity threshold was more than purity angle and within the acceptable range. Full length method was not performed; if it is done this method, it can be used for routine analysis of Baloxavir marboxil. The analytical procedure was specific and validated as per ICH guideline (Q2R1).