Abstract
In 2015, the Food and Drug Administration granted approval for the use of lumacaftor 200 mg and ivacaftor 125 mg in the treatment of cystic fibrosis patients who possess the F508del mutation, namely those who are 12 years of age or older. Since its approval, the medicine has been implemented in clinical settings, although the presence of numerous disputes, with the aim of mitigating disease symptoms and enhancing the overall quality of life. Given the existing gaps in the literature regarding the analysis of the amalgamation of these two active substances, a straightforward and practical HPLC approach has been devised in adherence to the guidelines outlined in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) document. To accomplish this objective, the process of separation was successfully carried out using a monolithic silica stationary phase (Chromolith High Resolution RP-18e, 100 mm × 4.6 mm i.d., Merck KGaA, Darmstadt, Germany). The separation process was conducted using a gradient mode. The initial composition of the mobile phase consisted of acetonitrile and a phosphate buffer solution with a concentration of 0.030 M and a pH of 3.5. The flow rate was recorded as 1.0 mL/min, and avanafil was used as an internal standard. The improved and verified approach has demonstrated successful application in bulk and pharmaceutical formulation evaluations when utilizing the ivacaftor/lumacaftor combination.
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