Azithromycin dihydrate is a semi-synthetic macrolide antibiotic drug, effective against a wide variety of bacteria.
It is primarily used to treat the bacterial infections associated with weaker immune system. A simple, accurate, rapid
and cost effective spectrometric method for the estimation of azithromycin has been developed and validated by the acidic
hydrolysis of the drug with sulphuric acid and monitoring the absorbance at 482nm. The validated method was successfully
applied for dissolution studies of azithromycin dihydrate tablets. The developed method was validated as per ICH Q2
(R1) guidelines, which include linearity, precision, accuracy, specificity, robustness, detection and quantitation limits. The
method has shown good linearity over the range of 10.0 to 50.0 µg/mL with a correlation coefficient of 0.9995. The percentage
recovery of 99.98 % showed that the method was highly accurate. The precision demonstrated relative standard
deviation of less than 2.5 %. The specificity of the method was proven as the excipients present in the tablets did not interfere
with the assay. The developed and validated method was successfully applied for dissolution studies with a cumulative
release of 99.3 % in 45 minutes. The proposed method might be applied in routine quality control in the pharmaceutical
industries as it has shown very good precision, accuracy and simplicity.
Keywords: Azithromycin dihydrate, acid hydrolysis, validation, ICH, UV-Vis spectrometry, quality control.
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