Abstract
AIM: A simple, precise, rapid and reproducible high performance liquid chromatography (HPLC) method was developed and validated for determining melatonin in capsule dosage form. METHODS: Chromatography was carried out on a Diamonsil C18 column (250 mm×4.6 mm, 5 μm) with a mobile phase (methanol: acetonitrile: 0.5% acetic acid solution = 4:1:5, v/v/v) at a flow rate of 0.5 mL/min. Detection was performed using a UV detector at 250 nm and 10 μL sample was injected. Parameters such as specificity, system suitability, linearity, robustness, precision, and accuracy were studied. RESULTS: The retention time and the mean percentage recovery for melatonin of the method were 15.69 ± 0.20 min and 99.36 %, respectively. The linearity range was 0.20-0.60mg/mL and the correlation coefficient (R) was 0.99817. The relative standard deviations (RSD) for all the parameters determined in this experiment were always less than 3.0 %. CONCLUSION: Therefore, the method can be successfully applied for routine analysis of melatonin in capsule dosage form.
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