Factorial design optimized green reversed-phase high-performance liquid chromatography for simultaneous determination of aspirin and clopidogrel in pharmaceutical tablets

A rapid, simple, and, green HPLC technique was performed for the simultaneous determination of aspirin (ASP) and clopidogrel (CLP) in tablets by using a 23factorial design model. The chromatographic separation was performed using a C18 analytical column (150x4.6 mm; 5 mu m), the mobile phase was a mixture of (70:30 v/v) ethanol: 0.08 M sodium dihydrogen phosphate, and the optimum pH was adjusted to 6 with o-phosphoric acid. Detection was monitored at 230 nm with a flow rate of 1 mL/min in a total runtime of 4 min. The modern technique of using full factorial permits the estimation of the studied drugs with the optimum quantity of chemicals to ensure the greenness of the method. The elution of the two drugs was less than 4 min where the retention time of aspirin and clopidogrel was found to be 1.52 and 3.28 min respectively.Calibration curves were found to be rectilinear over the range of concentration (0.5-10 mu g/mL) and with a correlation coefficient (r) = 0.9999 for both drugs. The limit of detection (LOD) was found to be 0.05 mu g/mL and 0.14 mu g/mL and the limit of quantitation (LOQ) was found to be 0.16 mu g/mL and 0.44 for ASP and CLP, respectively. The suggested method was applied for the determination of the drugs under study in bulk and their co -formulated tablets.The contents were found to be 100.38 +/- 0.95 and 100.12 +/- 0.87 for ASP and CLP respec-tively. The proposed method was validated according to the International conference on harmonization Guidelines ICH. The greenness of the method was confirmed by applying different assessment tools such as NEMI, GAPI, and Eco-scale methods.

Automated summary

A green HPLC technique using a 23 factorial design model was developed for the simultaneous determination of aspirin (ASP) and clopidogrel (CLP) in tablets. The method involved a C18 analytical column, a mobile phase consisting of ethanol and sodium dihydrogen phosphate, adjusted to pH 6 with o-phosphoric acid. The drugs were detected at 230 nm with a flow rate of 1 mL/min. The method was validated and found to be environmentally friendly based on various assessment tools.