A visible spectrophotometric method have been developed for the determination of entecavir monohydrate in pure and dosage forms using MBTH as chromogenic reagent. Present study is based on oxidation followed by coupling by 3-methyl-2-benzothiazolinone hydrazone with drug in the presence of cerric ammonium nitrate to form blue-green colored chromogen exhibiting absorption maximum at 624 nm and beer’s law is obeyed in the range of 15-55 µg/ml with coefficient of determination (r2) as 0.998. The limit of detection and limit of quantitation were found to be 1.6 µg/ml and 4.85 µg/ml respectively. The developed method has been validated as per the ICH Q2 (R1) guidelines. The results demonstrate that the method is linear, precise and accurate. The proposed method was successfully applied for determination of entecavir monohydrate in pharmaceutical dosage form (tablets) with good recovery and reproducibility.
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