Development and application of Liquid Chromatographic method for determination of Caspofungin Acetate in sterile, lyophilized powder for Injection

Caspofungin is an antifungal agent of the novel echinocandin class. Caspofungin, 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. Caspofungin 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 isocratic elution at a flow rate of 1.0 mL/min on X-Terra RP-18 column (250mm×4.6 mm, 5-µm particle size, 100Ã… 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 isocratic mode in the ratio of 30: 70 (v/v) of separation was used to resolute the Caspofungin. UV detection at 278 nm was employed to monitor the analytes. A linear response was observed for caspofungin over the concentration range 0.5'“6 -µg/ mL. Limit of detection (LOD) and Limit of quantification (LOQ) for Capsofungin were found to be 0.001-µg/mL, and 0.003-µg/mL respectively. Dr. L. Satyanarayana | Dr. Sumalatha Reddi"Development and application of Liquid Chromatographic method for determination of Caspofungin Acetate in sterile, lyophilized powder for Injection" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-3 , April 2018, URL: http://www.ijtsrd.com/papers/ijtsrd10927.pdf http://www.ijtsrd.com/pharmacy/pharmaceutics/10927/development-and-application-of-liquid-chromatographic-method-for-determination-of-caspofungin-acetate-in-sterile-lyophilized-powder-for-injection/dr-l-satyanarayana