Abstract
Background: Amoxicillin trihydrate is used a broad spectrum antibiotic for the treatment of diverse variety of bacterial infections. Aim: The objectives of the present study was an assessment of in vitro drug release profile and estimation of the drug content of the prepared in-house time-dependent release bilayer tablet formulations of amoxicillin trihydrate (AMT) employing a simple, rapid, sensitive and a cost effective reverse phase liquid chromatography method. Materials and Methods: The chromatographic separation was achieved using methanol and phosphate buffer (pH 3.5) at 50:50% v/v as mobile phase at a flow rate of 1 mL/min. Results: The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation and system suitability. The linearity was determined by residual analysis indicated good regression coefficient ( r 2 ) of 0.999 at a concentration ranging between 2 and 16 μg/mL. The assay of both in-house formulation and marketed preparation indicated good recovery of 99.95% and 99.60%, respectively. In vitro dissolution studies revealed that the prepared in-house tablet formulation showed time-dependent biphasic profile of drug release, whereas marketed preparation showed immediate release effect. Conclusions: The developed method, therefore, can be used for routine estimation of AMT in bulk and pharmaceutical dosage forms.
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