Determination of azithromycin in medicines by reaction with 2-nitrobenzaldehyde and validation of the procedure according to the State Pharmacopoeia of Ukraine
A precise and sensitive spectrophotometric procedure for the quantitative determination of azithromycin in pharmaceutical preparations based on the reaction with 2-nitrobenzaldehyde is developed. Validation characteristics such as linearity, application range, specificity, precision, accuracy and robustness are determined. The procedure is valid for carrying out «Assay» and «Dissolution» tests in solid preparations of azithromycin. The developed procedure has been included in the analytical normative documentation for capsules of azithromycin.
2. USP30-NF25, P.1472.
3. Validation of analytical methods and tests // State Pharmacopoeia of Ukraine / State Enterprise "Scientific Expert Pharmacopoeial Center". - First look. - Kharkiv: RIREG, 2001. - P. 58-67. - Supplement 1. - 2004. - P. 2-4.
4. Grizodub AI // Pharmacom. - 2002. - № 3 - P. 42-50.
5. Grizodub AI, Leont'ev DA, Denisenko NV etc. // Pharmacom. - 2004. - № 3 - S. С— 17.
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