Abstract Design of experiments has emerged as an influential and proactive approach that demonstrated favored applicability in optimizing chromatographic procedures. Quality-by-design guarantees the long-standing efficiency of the developed HPLC method reducing the need for costly and resource-intensive univariate approach. A low environmental footprint, sensitive, fast, and simple HPLC method was developed for concurrent estimation of cefixime (CFX) and ornidazole (ORN) in their raw materials, laboratory-prepared tablets, and pharmaceutical formulations using 2 3 full factorial design. The separation was performed on a cyano column through UV detection at 300 nm in less than 4 min. The elution was achieved using a mobile phase (pH = 6. 0) composed of methanol and 0. 3% triethylamine in ratio of (85%: 15%, v/v), respectively with a flow rate of 1 mL/min. The method’s validity was established with ICH \: Q₂R₁ regulations. Excellent linear correlation (r = 0. 9999) was established within concentration ranges lies between 1 and 50 µg/mL and 0. 5–50 µg/mL with high percent found of 100. 04 ± 0. 82 and 99. 99 ± 1. 01 for CFX and ORN, respectively. The approach exhibited high precision (% RDS < 2) and sensitivity with detection limits of 0. 07 and 0. 09 µg/mL and quantification limits of 0. 21 and 0. 28 µg/mL for CFX and ORN, respectively. Several metrics evidenced the method’s greenness and sustainability profile.
Mostafa et al. (Tue,) studied this question.