Green and High Throughput HPTLC Method for Simultaneous Estimation of Celecoxib and Tramadol Hydrochloride in their Newly Approved Analgesic Combination and Spiked Plasma with Dichromic Green and Blue Assessments

Abstract

The FDA “Food and Drug Administration” recently approved a novel co-crystal formulation of Celecoxib (CEX) and Tramadol (TRM) for the treatment of adults suffering from moderate to severe pain in several conditions. This novel combination has advantages over co-administration of the two drugs individually as better patient compliance, synergism and lower therapeutic cost. This work presents the first “High performance Thin Layer Chromatographic” (HPTLC) quantitative analytical technique for CEX and TRM simultaneous assay in bulk, their new dosage form and plasma. The proposed HPTLC assay is based on separation of CEX and TRM on silica gel 60 F254 sheets followed by densitometric scanning at 270 nm. The plates’ development was carried out using a mobile phase of ethyl acetate–methanol–ammonia (5:5:0.05, v/v). The two drugs showed linearity of 0.025–1 μg.band⁻¹ & for plasma analysis linearity range was 0.2–10 μg.mL⁻¹ plasma. The proposed chromatographic technique was validated and showed satisfying validation characteristics of linearity, selectivity, precision and accuracy. In addition, the assay was evaluated by AGREE, AGREEprep, ComplexMoGAPI and BAGI for greenness and blueness to ensure the method’s environmental sustainability and its safety for routine quality control assay of this novel combination.