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Analytical validation study demonstrates simultaneous purity and quantity assessment in multi-component drug formulations, highlighting eco-friendly pharmaceutical quality control.
In the current study, eco-friendly, simple, accurate, and selective univariate techniques were validated to evaluate a quinary mixture consisting of Rabeprazole (RB), Lansoprazole (LN), Amoxicillin (AM), Levofloxacin (LV), and paracetamol (PR) in the laboratory-prepared mixture and tablet formulations. Novel approaches, including pure spectrum extraction (PSE), the pure component contribution algorithm (PCCA), and constant multiplication (CM) were developed. Each method was combined with subtraction spectrum (SS) to determine each drug at its respective λmax. The extended spectra of LV at 298 nm were extracted using (CM-SS), the D0 spectra of RB at 288 nm and LN at 286 nm were retrieved with (PSE-SS). PR and AM were determined at 250 nm and 234 nm, respectively, using (PCCA-SS). The spectral ratio factor (SRF) and the spectral contrast angle (COSƟ) were established to measure the accuracy and validity of the retrieved signals. The results were statistically compared with reported methods, and validated per ICH guidelines. Additionally, the greenness and whiteness were assessed of the proposed techniques along with the reported methods, the results indicate the sustainability and echo-friendly of proposed techniques.
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Amin et al. (2026) studied this question.
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