Validation and Assessment of Stability Indicating RP-HPLC Method For Salbutamol Sulfate in Inhalational Solution and Forced Degradation Study

Abstract

RP-HPLC SIAM has been developed and validated for the assessment of salbutamol sulfate in inhalational solution on an adopted compendial method. The method was tested for its feasibility and specificity to separate the principal component, related substances and impurities from the prepared in-house formulation undergoing stability studies. The studies elaborate feasibility testing of adopted method optimization of forced degradation studies to achieve 10-30% degradation of API as such and in formulation. The API and formulation were exposed to stressful condition for 7 days and the were analyzed using a waters column Symmetry C8 (150mm x 3.9mm) 5μm make waters or equivalent at 25°C on a flow rate of 1.0mL/min for over 50 minutes Detection wavelength used was 220nm ACN and Phosphate buffer of pH 3.65 as composite mobile phase. The optimized method was then validated as per the ICH guidelines(Q2A).