A Sensitive UV Spectrophotometric Analytical Method Development, Validation and Preformulation Studies of Clarithromycin

Clarithromycin is a broad spectrum macrolide antibacterial agent effective against Helicobacter pylori a major pathogen which causes peptic ulcer disease. A sensitive analytical UV spectrophotometric method was developed to quantitate the drug either in bulk or in formulations. Wave length scans of clarithromycin showed its absorption maxima at 211 nm. Linearity studies indicated that estimation of clarithromycin obeyed beers law limit between 2.00 μg/ml to 10.00 μg/ml with regression equation of y = 0.0250*X -0.0010; (r² = 0.999). The low SD values of Inter day and Intraday variation studies indicated that the variation is minimum. Limit of Quantitation of clarithromycin was found to be of 1.5 μg/ml. Hence the above analytical parameters indicated that the developed UV Spectrophotometric method of clarithromycin was sensitive, accurate and reproducible. Preformulation studies showed that clarithromycin melting point as 222.6°C, the solubility of drug followed the order acetone > ethanol >methanol > pH 1.2 > pH 4.0 > pH 7.4 > pH 9.0. Further the log p value of clarithromycin was observed as 1.170. The method was found to be precise and can be applied for routine analysis of drug in different pharmaceutical dosage forms and also for dissolution studies.