1Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, SAUDI ARABIA
2Department of Biomedical Sciences, College of Clinical Pharmacy, King Faisal University, ARABIA
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ABSTRACT
Background
The combination of two drugs celecoxib + tramadol and diclofenac sodium + tramadol with different mechanisms of action is better for achieving effective pain control.
Materials and Methods
The simple reproducible mathematically modified UV spectroscopic methods were established for concomitant evaluation of the binary combination of celecoxib + tramadol and diclofenac sodium + tramadol formulations. The first technique is predicated on separating the pure zero-order spectra of TDL and CCB from the mixture spectra and quantification at their lambda max. The second and third method involves the ratio absorption difference and ratio first derivative spectroscopic method for quantification of DFS and TDL. Additionally, we followed ICH guidelines to validate these approaches for specificity, accuracy, and precision.
Results
Both formulations were effectively analyzed using the proposed methods, with results falling into the series of 2-50 μg/mL for TDL, and 1-30 μg/mL for DFS and CCB. The good recovery of 98.56% -101.48% with low relative error and percentage relative standard deviation verified the methodologies’ correctness and repeatability. Finally, proposed mathematically modified spectroscopic procedures were exploited for quality control of analytes from formulation and manually prepared mixtures. The determination of % of retrieval of an added known quantity of authentic medications of CCB, TDL, and DFS to the powdered pill served as additional evidence of correctness.
Conclusion
The established UV spectroscopic techniques are simple, rapid, and perfect for simultaneous quantification of CCB, DSF, and TDL from the solid dosage forms. The assay results also confirmed the nonexistence of tablet adjuvants intervention in the quantification of medicines in the tablets Therefore, these approaches can be utilized for systematic quantification of these drugs in the binary formulations without chemical separation.