STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF SOTORASIB IN ITS PHARMACEUTICAL DOSAGE FORMS
Keywords:
Sotorasib, Method development, Validation, RP-HPLC..Abstract
A precise approach based on RP-HPLC methodology was developed for Sotorasib estimation. Using stationary phase BDS 150mm x 4.6 mm, 5m, mobile phase 0.01N, the chromatographic conditions employed are Acetonitrile in a 70:30 ratio maintained a flow rate of 1 ml/min, a detection wave length of 268 nm, a column temperature set to 30 oC, and a mobile phase diluent ratio. Conditions were settled as best approach. By injecting the standard six times, system suitability parameters were investigated and results fell well under the acceptance requirements. Between 25% and 150% levels, linearity studies revealed an R2 value of 0. 999. Repeatability determined to be 0.1; intermediate precision found to be 0.3.LOD and LOQ are respectively 0.28μg/ml and 0.83μg/ml. Using aforesaid approach test of marketed formulation resulted in 99.54% presence. Sotorasib's degradation investigations revealed that within the permissible range and in every condition's purity threshold was more than purity angle. The whole length approach was not followed; so, this technique may be applied for regular Sotorasib analysis.
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