The stability-indicating LC assay method was developed and validated for quantitative determination of cefcapene pivoxil in the presence of degradation products formed during forced degradation studies. An isocratic RP-HPLC method was developed with a Lichrospher RP-18 (250 mm × 4.6 mm, 5 μm) column and the mobile phase composed of 45 volumes of acetonitrile and 55 volumes of mixture composed o...

Stress-testing (forced degradation) studies have been conducted on pemetrexed disodium heptahydrate (1) (LY231514·2Na·7H2O) drug substance in order to identify its likely degradation products and establish its degradation pathways. Solid samples of the drug substance were stressed under various conditions of heat, humidity, and light, and solutions of the drug substance were stressed under vari...

A novel, stability-indicating high-performance liquid chromatographic (HPLC) method is delivered for the determination of fluphenazine hydrochloride (FPZ) and its degradation products. The forced degradation testing of FPZ was carried out for hydrolytic, oxidative, photolytic, and thermal degradation. The degradation appeared using a reversed-phase C18 column at ambient temperature with a mobil...

A validated, specific, stability indicating reversed-phase liquid chromatographic method has been developed for quantitative analysis of citicoline and its related substances in oral drops formulation. Forced degradation studies were performed using acidic, basic and oxidizing conditions, and thermal and photolytic stress, to show the stability indicating power of the method. The method was opt...

The current study describes the short, stability indicative HPLC method development and successive validation of Assay Related Substances methods for Vilazodone Hydrochloride API. This also covers process impurities viz. Impurity A B. chromatographic conditions are similar except sample concentration. proposed utilizes C18 column (15 cm X 4.6 mm, 5 µ, make ZORBAX SB) mobile phase having Methano...