DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE DETERMINATION OF RAMELTEON IN BULK AND PHARMACEUTICAL DOSAGE FORM

PHARMACY

Abstract: A simple, accurate and precise reverse phase HPLC method validated for the determination of Ramelteon Tablet dosage form. Chromatography was carried on C18 column using a mixture of Methanol: water (0.1 % OPA), pH 2.7 (in the ratio 60:40 v/v) as the mobile phase at a flow rate of 0.7 ml /min with detection at 282 nm by ultraviolet detector i.e. incorporated in HPLC. The retention time of the drug was found to be 5.860 min. The method validation proofs were carried out as per the ICH guidelines. The developed method was validated for linearity over a range of 10μg/ml to 60μg/ml, with a correlation coefficient of 0.999, which shows the method is quite linear. Further precision, ruggedness, accuracy was validated. The %RSD for system precision was observed to be Less Than 2, whereas the method precision was observed to be 0.456. And for ruggedness the observations were found to be 0.5 and 0.4 respectively. The average recovery of 100.0% indicates the capability of the method, and finally no significant differences in % RSD values with respective Retention time prove the robustness of the method. As per ICH guidelines, method validation results are in good agreement. The proposed approach is effective and can be applied for the tablet dosage form estimation of Ramelteon in tablet dosage form.

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