Current Issue : January-March Volume : 2023 Issue Number : 1 Articles : 5 Articles
The quality of marketed pharmaceutical formulations must be guaranteed to attain better remedial effects and lower toxicity. The wide exploitation of antibiotics may lead to their presence as residues in body fluids and wastewaters, potentially toxic to human health. Consequently, determining antibiotics in pharmaceutical formulations and water samples is of significant importance. This paper aims to explore the possibilities of a high‐performance liquid chromatography coupled with diode array detection (HPLC‐DAD) method to obtain a simple, fast, and efficient analytical tool for the simultaneous determination of antibiotics in pharmaceutical formulations and environmental samples. The method was completely validated with regard to specificity, linearity, detection and quantification limits, precision, accuracy, and robustness according to the requirements of existing guidelines, and was proven to be reliable and suitable for the envisioned application. The linearity study was conducted for the calibration curves in the range of 10–100 μg/mL. The limits of detection and quantification were found to be 0.2 and 0.7 μg/mL for amoxicillin and 0.3 and 1.0 μg/mL for doxycycline, respectively. The high recovery of drugs from their commercial pharmaceutical formulations (93%) and from wastewater samples (98%) indicated good accuracy and precision. The method is robust for small or deliberate changes to the chromatographic parameters, and it was successfully applied for the quantitative determination of amoxicillin and doxycycline in wastewater and commercial tablets. The obtained results proved that the validated method is appropriate for its intended use in the routine quality control and assay of both antibiotics studied....
One of the most prevalent over-the-counter cold and cough medications is the chlorpheniramine maleate (CPM)–ibuprofen (IBF) combination. A reversed-phase high-performance liquid chromatography (RP-HPLC) method was effectively optimized and developed for the simultaneous detection of chlorpheniramine maleate and ibuprofen in a pharmaceutical formulation. The mobile phase for the RP-HPLC method was an isocratic combination of acetonitrile and 0.01 M acetate buffer at pH 3.8 (55:45; v/v) on an Eclipse Plus C18 reversed phase column. An ultraviolet (UV) detector with a wavelength of 225 nm was used to detect the analytes at a flow rate of 1.0 mL/min. CPM and IBF were satisfactorily eluted, with mean retention times of 2.09 and 6.27 min, respectively. The approach was shown to be linear (R2 > 0.9998 for CPM and 0.9992 for IBF), precise (% RSD 3.02% for CPM and 3.48% for IBF), accurate (% recoveries 97.7–98.9% for CPM and 101–104.5% for IBF), specific, easy to use, sensitive, quick, and robust. Limits of detection (LODs) were found to be 10 and 27 μg/mL for CPM and IBF, respectively. Without interference from excipients, the validated method could be utilized in regular quality control analysis of various dosage combinations of hard gelatin capsules containing CPM and IBF...
Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLCESI- MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were m/z 359.15 > 279.10 and m/z 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible....
A new probe based on the complex of 1,2 dihydro-2-oxoquinoloine-4-carboxylic acid (DOCA) as a ligand with Europium (III) ion was developed for the quantitation of Moxifloxacin HCl (Moxi.HCl) in pharmaceuticals and human plasma using a luminescence method. The metal to ligand ratio of the complex is 1:2 as determined by a Job plot. The determination of Moxi.HCl is based on static quenching of the luminescence of the probe upon coordination of Moxi.HCl. The negative value for ΔG proves that this reaction is spontaneous. The calibration curve was constructed based on a Stern–Volmer equation and the quantitation range was 0.05–80 μg mL−1. This is low enough to determine the drug in blood plasma, even hours after administration, which is not feasible with the methods published so far. The LOD was 15 ng mL−1. The accuracy of the method was demonstrated by good recoveries of spiking experiments in tablets, ophthalmic eyedrops and human blood plasma, where the mean recovery was 99% with RSDs below 5%. The method was validated by closely matching concentrations of the drug found in all these real samples by HPLC. Additionally, Moxi.HCl can be assessed semi-quantitatively by eye vision upon excitation with a UV lamp at 365 nm by a gradual color shift from red to blue with increasing concentrations of Moxi.HCl....
Antipsychotics are widely used to treat various mental disorders. Combination therapies were approved by the FDA to treat manic states. Quetiapine fumarate, aripiprazole, asenapine maleate, and chlorpromazine HCl are frequently used for treatment of these disorders. Green analytical chemistry is primarily concerned with reducing waste generated during sample preparation or analysis. Green solvents, such as ethanol, are being used in HPLC as an alternative to acetonitrile. To this purpose, two new chromatographic methods were developed to determine these four drugs simultaneously in their bulk and pharmaceutical formulations. The greenness of both methods was assessed by the green analytical procedure index (GAPI)—one of them was found to be green ecofriendly, and the other had some environmental hazards (conventional)—and this helps laboratories to choose a method that suits their capabilities. The chromatographic separation for both methods was carried out on a Thermo® C18 column. The total separation times were about 11 min and 9 min for the green and the conventional methods, respectively. Using the Student’s t-test and the F-ratio, there was no significant difference between the results of the two methods. These methods have been validated and successfully applied to the analysis of commercial pharmaceutical formulations. Our study could successfully be used in central quality control laboratories, which need a single analytical method to separate more than one compound with similar pharmacological action....
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