Indian Journal of Pharmaceutical Education and Research, Journal Year: 2024, Volume and Issue: 58(2s), P. s606 - s615
Published: May 28, 2024
Background Methotrexate (MTX) is one of the utmost commonly prescribed drugs, which official in IP, BP, and USP. MTX a potent drug that can cause serious side effects if not used correct quantity. Assaying vital to guarantee exists required concentration sample. Developing simple, rapid, cost-effective analytical tool for its estimation has always been thrust area research. In this line, investigation reports low-cost Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method with an ultraviolet detection channel estimating bulk samples. Materials Methods The technique employs isocratic mobile phase comprising readily available solvent system having 50 mM sodium acetate buffer (pH-3.6) acetonitrile 90:10, v/v, flows through column at constant flow rate 1.0 mL/min. A Thermo C-18 Column (5-micron, 250 mmx4.60 mm) was as stationary separation. Considering optimized chromatography parameters, sensitivity, selectivity 307 nm selected wavelength UV-visible detector. validation studies were performed by fulfilling requirements ICH guidelines. Results Conclusion found be specific, linear (including intra- inter-day precision), accurate, precise routine testing MTX. developed RP-HPLC successfully applied determine standard Laboratory Bulk samples commercial Dosage Formulations, well monitor release kinetics from in-house Nanoformulation. represents valuable laboratory analysis monitoring during quality control toxicity studies.
Language: Английский