Development and application of Liquid Chromatographic method for determination of Carvoverine in bulk and in Intramuscular injection dosage forms

Abstract

Carvoverine is an antifungal agent of the novel echinocandin class. Carvoverine, the first inhibitor of fungal b-1,3
glucan synthesis to receive approval by the United States Food and Drug Administration, is effective for the treatment of
mucosal and invasive candidiasis and invasive aspergillosis. It is also active in vitro and in animal models against a number
of other filamentous and dimorphic endemic fungi and in animal models of Pneumocystis carinii infection. Carvoverine is a
water-soluble amphipathic lipopeptide is a semisynthetic derivative of pneumocandin B0, a fermentation product of Glarea
lozoyensis. Developing a accurate and precise alytical method for the estimation of cagpsofungin in a sterile, lyophilized
product for intravenous (IV) infusion a is very challenging, due to the formation of drug-drug and drug-excipient
interactions. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single
HPLC method for the quantitative determination of antifungal agents in freeze dried powder for injection pharmaceutical
dosage form. Chromatographic separation active pharmaceutical ingredient was achieved by using a Gradient elution at a
flow rate of 1.0 mL/min on Zorbax Eclipse XDB-C18 (250mm×4.6 mm, 5μm particle size, 100Å pore size) at ambient
temperature. The contents of the mobile phase were 3.48 gms of Di Potassium hydrogen ortho-phosphate (0.03M) in 1000 ml
of water and by adjusting the pH to 3.2 with dilute ortho-phosphoric acid (mobile phase solvent-A) and Acetonitrile (mobile
phase solvent-B) in a Gradient mode in the ratio of 30: 70 (v/v) of separation was used to resolute the Carvoverine. UV
detection at 260 nm was employed to monitor the analytes. A linear response was observed for Carvoverine over the
concentration range 4-48 μg/ mL. Limit of detection (LOD) and Limit of quantification (LOQ) for Carvoverine were found to
be 0.04μg/mL, and 0.12μg/mL respectively.