The isolation of Azithromycin in Azithromycin Powder for oral suspension using liquid-liquid extraction, development of stability-indicating method followed, an analytical method validation using HPLC for quantification of probable impurities of Azithromycin in Azithromycin for oral suspension. The critical separation between impurities after isolation from sample matrix of the drug product is achieved on X Bridge® C18, 5µ, 250 x 4.6mm column. pH 9.5 disodium Phosphate buffer (20mM) is phase A, acetonitrile and methanol in the ratio 75:25v/v is phase B in gradient elution. The flow is maintained at 1.0 mL/min, 210nm was fixed for quantification purpose at 60°C. Method is validated as per ICH recommended parameters. HPLC method is highly beneficial for determination of impurities of Azithromycin in Azithromycin for oral suspension. Liquid-liquid extraction eliminates the intervention of the complex placebo peaks which interferes with impurities related to Azithromycin.
Keywords: Azithromycin, Liquid-Liquid Extraction, Stability demonstrating and HPLC
How to cite this article: Padmakar GV, Vittal SP, Vasundhara D, Suryakala D; Isolation of Azithromycin Using Liquid-Liquid Extraction in Azithromycin for Oral Suspension Formulation and Separation of Impurities by Using HPLC. Int J Drug Deliv Technol. 2026;16(1): 472-480. DOI: 10.25258/ijddt.16.1.50