VALIDATION AND ASSESSMENT OF STABILITY INDICATING RP-HPLC METHOD FOR SALBUTAMOL SULFATE IN INHALATIONAL SOLUTION

Abstract

RP-HPLC SIAM was 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 they were analyzed using a waters symmetry C (150mm X 3.9mm, 5μm) column at 25°C on a flow rate of 1.0mL/min for over 50 minutes. The mobile phase was prepared by mixing 220 mL acetonitrile and 780 mL phosphate buffer (pH 3.65). Detection wavelength used was 220nm. The optimized method was validated as per the ICH guidelines(Q2A).