A QbD-led Simple and Sensitive RP-UHPLC method for Simultaneous Determination of Moxifloxacin, Voriconazole, and Pirfenidone: An Application to Pharmaceutical Analysis.

A novel, quick, and precise RP-UHPLC analytical method for simultaneous determination of moxifloxacin (MFX), voriconazole (VCZ), and pirfenidone (PIR) was developed and validated according to the ICH guidelines using QbD driven response surface Box Behnken design. The developed method was validated considering selectivity, sensitivity, linearity, accuracy-precision, robustness, stability, the limit of detection and limit of quantification, respectively. The resolution between MFX, VCZ, and PIR was achieved using gradient elution protocol against Waters Symmetry Shield C18 column (150 × 4.6 mm 2 , 5 μ) using Agilent 1290, Infinity II series LC system. The method was applied to quantitatively estimate proprietary and in-house prepared pharmaceutical topical ophthalmic formulations containing MFX, VCZ, and PIR at λ max of 296, 260, and 316 nm. The method is sensitive enough to detect upto 0.1 ppm of analytes in the formulation. The method was further exploited to study and identify the possible degradation products of the analytes. The proposed chromatographic method is simple, economical, reliable, and reproducible. In conclusion, the developed method could be applicable for routine quality control analysis of single or a combination of MFX, VCZ, and PIR-containing unit or bulk dosage forms in pharmaceutical industries and research organizations working on drug discovery and drug development.