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Designing new validated analytical procedures with a focus on many objectives, such as simplicity, environmental friendliness, analytical effectiveness, and sustainability, has grown to be a top priority in quality control departments. Applying green and white analytical chemistry concepts is no longer a luxury. In this report, two new approaches, Capillary Zone Electrophoresis (CZE) with Photo Diode Array (PDA) detection and derivative ratio spectrophotometric methods, are established and validated for the simultaneous analysis of molnupiravir (MLP) and favipiravir (FAV) in bulk, single dosage forms, and their expected combined dosage forms. For the two drugs, linearity ranges of 5–50 μg/mL and 1–30 μg/mL were achieved using the CZE and spectrophotometric methods, respectively. Both techniques have been validated and used for the estimation of the two medications in lab‐made capsules in accordance with the International Council for Harmonization's (ICH) recommendations. Seven assessment models were used to evaluate the greenness and sustainability of the introduced approaches compared to three previously published HPLC, chemometric, and HPTLC techniques. ChlorTox and BAGI tools are applied for the first time for the evaluation of an analytical procedure. Higher green and sustainable qualities were declared by suggested approaches than by earlier ones. [ABSTRACT FROM AUTHOR]

A simple, rapid, and low‐cost technique was developed to allow reliable analysis of the anti‐hepatitis C drug sofosbuvir in bulk, tablet form, and spiked human plasma. This method depends on the ability of sofosbuvir to quench the fluorescence of the newly synthesized 2‐amino‐3‐cyano‐4,6‐dimethylpyridine (reagent 3). Elemental analysis and spectral data were used to validate the structure of the synthesized reagent. The newly synthesized reagent exhibited a satisfactory level of fluorescence emission at 365 nm after excitation at 247 nm. All experimental variables that might affect the quenching process were analyzed and optimized. Linearity, range, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ) were all validated in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The concentration range was shown to be linear between 0.1 and 1.5 μg/mL. The technique was effectively utilized for sofosbuvir analysis in both its tablet dosage form and spiked human plasma, with mean percentage recoveries of 100.13 ± 0.35 and 94.26 ± 1.69, respectively. [ABSTRACT FROM AUTHOR]

An understanding of drug product degradation issues is needed to advise stable formulation and provide a reasonable shelf‐life evaluation for all drug products. For this purpose, we have developed and validated a novel HPLC method for assessing the stability of vardenafil and dapoxetine in a combined pharmaceutical dosage form. The chromatographic separation was accomplished on a ProntoSIL C18 KROMA PLUS column (250×4.6 mm, 5 μm). The column was run under isocratic conditions with a 2.0 mL/min flow rate. The mobile phase was made up of methanol and 20 mM potassium dihydrogen phosphate at 45 : 55 (v/v), which was adjusted to pH 3.0 with phosphoric acid; these two drugs were eluted at retention times of 5.33 and 9.91 min for vardenafil and dapoxetine, respectively. The proposed method shows a linearity of 1–50 ug/ml with a regression of 0.9999 for both drugs. The method was validated for accuracy, precision, linearity, specificity, and sensitivity. The developed HPLC method has been successfully implemented to analyse dapoxetine and vardenafil in tablets. Furthermore, the stress degradation experiments were conducted on the bulk powder of vardenafil and dapoxetine following the International Council for Harmonization (ICH) recommendations. [ABSTRACT FROM AUTHOR]

Antimicrobial agents are essential to protect human and animal health. During the coronavirus disease 2019 pandemic, antimicrobials such as cephalosporins were widely used as prophylactics and to prevent bacterial co‐infection. Undoubtedly, the prevalence of antibiotics in the aquatic environment will ultimately affect the degree of resistance against these bacteria in animals and the environmental systems. In order to monitor 16 cephalosporins in the aquatic environment, we developed a new liquid chromatography‐tandem mass spectrometry method that functioned simultaneously under positive and negative electrospray ionization switching modes. The chromatographic separation has been implemented using a pentafluorophenyl propyl column kept at 40°C. The limits of detection and quantitation for the studied cephalosporins ranged from (8 × 10−4) to (7.11 × 10−2) ng/ml and from (2.61 × 10−3) to (2.37 × 10−1) ng/ml, respectively. The percent extraction efficiency (apparent recovery) and relative standard deviations for the analyzed cephalosporins ranged from 61.69% to 167.67% and 2.45% to 13.48%, respectively. The overall findings showed that the effluent from the wastewater treatment plants that receive wastewater from pharmaceutical factories had a higher detected amount of cephalosporins than that of domestic sewage. Moreover, seven cephalosporins, including cefuroxime, ceftazidime, cefradine, cefprozil, cefixime, cefalexin, and cefadroxil (0.68–105.45 ng/L) were determined in the aquatic environment. [ABSTRACT FROM AUTHOR]

A fast, uncomplicated, sensitive and fully validated high‐performance liquid chromatography–tandem mass spectrometry (HPLC–MS/MS) method has been developed for estimating l‐amino acids in the plasma of schizophrenic patients. The gradient‐elution chromatographic method was implemented with the Luna® PFP column (50 × 2.0 mm, 5 μm), and a mobile phase of 0.1% formic acid in water and methanol was used. The intra‐ and interday variability of the l‐amino acids was <13.11%, their accuracy ranged from 85.14 to 116.75% at the quality control levels and the lower limit of quantification ranged from 2.5 to 15 nm. The extraction efficiency (apparent recovery) of amino acids from healthy plasma was employed by spiking the plasma with standard amino acids at the quality control levels. Their percentage recoveries ranged from 80.4 to 119.94%. Our method has a short run time and fast sample preparation compared with existing methods, which suffer from long preparative steps and/or time‐consuming analysis, restricted reagents and the suboptimal performance characteristics of presently available technologies. Therefore, the proposed HPLC–MS/MS method was effectively applied for monitoring the l‐amino acids in the plasma of schizophrenic patients and healthy volunteers. [ABSTRACT FROM AUTHOR]