Spectrophotometric Determination of Aspirin and Omeprazole in the Presence of Salicylic Acid as a Degradation Product: A Comparative Evaluation of Different Univariate/Multivariate Post Processing Algorithms

Abstract

Background A recent combination of aspirin (ASP) and omeprazole (OMP) has been presented in a fixed dosage form for treatment of many CVD, particularly in patients with gastric diseases. However, ASP is very sensitive to degradation into salicylic acid (SAL) as its main degradation product. Hence, it is very important to develop methods for the determination of ASP and OMP in the presence of SAL. Objective In this study, UV spectrophotometry assisted by different univariate/multivariate post processing algorithms have been presented for quantitative determination of ASP, OMP and SAL without any prior separation. Methods The univariate/multivariate algorithms include double divisor ratio difference and double divisor mean centering as the univariate approaches while the multivariate methods include principal component regression (PCR) and partial least squares (PLS) models. Validation of the univariate methods was done according to the ICH guidelines while the multivariate models were validated using external validation set. Results The univariate algorithms displayed excellent regression and validation capabilities in terms of linearity, accuracy, precision, and selectivity. Regarding PCR and PLS, the number of latent variables were carefully optimized, and the model’s validation criteria displayed excellent recoveries and lower errors of prediction. Conclusion Our findings indicate that the developed methods were comparable to the only reported chromatographic methods but with much shorter analysis time and simplicity. Highlights Overall, this report presents the first spectrophotometric methods applied for determination of possible combination of ASP, OMP, and SAL, and poses theses methods as valuable analytical tools in in-process testing and quality control analysis.

Spider diagram and sustainability evaluation of UV-methods strategy for quantification of aspirin and sildenafil citrate in the presence of salicylic acid in their bulk and formulation

“…1 A, which is an antiplatelet drug that lowers the risk of cardiovascular diseases mortality [ [6] , [7] , [8] ]. Some methods used for the quantification of ASA like HPLC [ 9 ], spectrophotometric [ 10 ], UHPLC [ 11 ], TLC [ 11 ], and UPLC [ 12 ]. These methods are shown in Table 1 .…”

“… Drug analyzed Method studied Publication year Reference Aspirin + Methocarbamol in the apparition of guaifenesin and salicylic acid. HPLC-DAD method 2019 [ 9 ] Aspirin + Omeprazole in the apparition of Salicylic Acid Spectrophotometric methods 2022 [ 10 ] Aspirin + Omeprazole in the presence of salicylic acid UHPLC and TLC 2021 [ 11 ] Aspirin + Salicylic acid + Salvianolic acid B UPLC-MS/MS 2021 [ 12 ] Sildenafil citrate + Dapoxetine + Vardenafil + Tadalafil Spectrofluorimetric and Spectrophotometric methods 2020 [ 15 ] Dapoxetine + Sildenafil Spectrophotometric methods 2022 [ 16 ] Sildenafil citrate Infrared Spectroscopic method 2021 [ 17 ] Sildenafil HPLC 2020 [ 18 ] Aspirin + Sildenafil citrate Spectrophotometric method 2015 [ 19 ] Aspirin + Sildenafil citrate Spectrophotometric methods 2022 [ 20 ] Aspirin + Sildenafil citrate + Salicylic acid HPLC 2014 [ ...…”

A New Chemometrically Assisted UV Spectrophotometric Method for Simultaneous Determination of Tamsulosin and Dutasteride in Their Pharmaceutical Mixture

“…Hence, to evaluate the built models’ performance , statistical parameters such as root-mean-square error of calibration and predictions (RMSEC and RMSEP) have been calculated, as shown in Table 5 . In addition, percentage of the relative root MSEP (RRMSEP) was used to measure the accuracy of the predictions ( 29 ), while bias-corrected MSEP (BCMSEP) was used to measure the precision or variance of the predictions ( 30 ), as shown in Table 5 . Specificity of the method has been assessed using the external validation set, and good results were attained as indicated by their RMSEP.…”

Spectrophotometric Investigations of Some Non-steroidal anti-inflammatory drugs (NSAIDs): A Brief Review

“…The method was used for the analysis of aspirin in drug formulations in different proprietary tablets. Manal E. et al [15] developed a spectrophotometric method for the determination of aspirin and omeprazole in the presence of salicylic acid as a degradation product. Different univariate/multivariate post-processing algorithms are used to analyze ASP, OMP, and SAL quantitatively, without any prior separation.…”