Abstract
A novel stability-indicating LC assay method was developed and validated for quantitative determination of Rifabutin in bulk drugs and in pharmaceutical dosage form in the presence of degradation products generated from forced degradation studies. An isocratic, reversed phase LC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250 x 4.6 mm, 5 µm) column, and 50 mM ammonium acetate (pH-4 by acetic acid) and acetonitrile (50:50v/v) as a mobile phase. The detection was carried out at the wavelength of 275 nm. The Rifabutin was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Degradation was observed for Rifabutin hydrolysis (acid, base), oxidation and photolysis conditions attempted. There is no degradation in thermal condition. The degradation products were well resolved from the main peak. The percentage recovery of Rifabutin ranged from (99.42 to 100.27%) in pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy (recovery), precision, specificity and robustness. The forced degradation studies prove the stability-indicating power of the method. Key words: Rifabutin, column liquid chromatography, stability indicating method, validation.
Highlights
Rifabutin is chemically known as (Figure 1; 4-deoxo-3, 4[2-spiro-(N-iso- butyl - 4 - piperidyl) - 2, 5 - dihydro - 1H imidazo] - rifamycin-S), a semisynthetic derivative of rifampicin S, that has shown broad-spectrum antibacterial activity against Gram-positive and Gram-negative organisms, including mycobacteria
Rifabutin was found to have activity against Mycobacterium aviumintracellular isolated from patients with AIDS (Heifets, 1987) has been approved for prophylaxis of combination therapy containing rifampin.Disseminated Mycobacterium avium complex (MAC) in patients infected with human immunodeficiency virus (HIV)
LC method was to achieve the resolution between rifabutin and its degradation products
Summary
Rifabutin is chemically known as (Figure 1; 4-deoxo-3, 4[2-spiro-(N-iso- butyl - 4 - piperidyl) - 2, 5 - dihydro - 1H imidazo] - rifamycin-S), a semisynthetic derivative of rifampicin S, that has shown broad-spectrum antibacterial activity against Gram-positive and Gram-negative organisms, including mycobacteria. Prophylactic treatment with rifabutin was shown to decrease the incidence of MAC by approximately 50% in AIDS patients enrolled in two randomized, placebo - controlled clinical trials (Nightingal, 1993). Its effect is based on blocking the DNAdependent RNA-polymerase of the bacteria. It is effective against Gram-positive and some Gram-negative bacteria, and against the highly resistant Mycobacteria, e.g. Mycobacterium tuberculosis, Mycobacterium leprae and Mycobacterium avium intracellulare
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