Development and Validation of a Simple and Sensitive Spectrometric Method for Estimation of Azithromycin Dihydrate in Tablet Dosage Forms: Application to Dissolution Studies

Vinay      Kumar; Sachin Kumar      Singh; Monica      Gulati; Renuka; Ranjith      Anishetty; Tamilvanan      Shunmugaperumal

Abstract

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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