“Method Development and Validation for Estimation of Melatonin in Oro- Dispersible Effervescent Tablet By RP-HPLC

M. Pharmacy

In the present research work, successful attempt was made for Estimation MEL in Orodispersible Effervescent tablet using HPLC method. The simplicity, rapidity, reproducibility and economy of proposed method completely fulfil the objective of this research work.HPLC method was developed and validated as per ICH guideline. Developed method was found to be simple, precise and accurate. Using Column C18 Hypersil ODS. The mobile phase was composed of methanol: phosphate Buffer (40:60), detection was done at 223nm. Retention time was found to be 7.1min.There were no methods for estimation of Melatonin in Oro dispersible effervescent tablet. The following method had been developed for estimation of Melatonin in effervescent formulation.Method Development and Validation for Estimation of Melatonin in Effervescent Tablet by RP-HPLC.A new RP-HPLC method was developed for assay of Melatonin in formulation. The separation was achieved on column C18 ODS (Hypersil), 250 nm×4.6 mm, 5µm using methanol: Phosphate Buffer (40:60) use as mobile phase for estimation of Melatonin. Detection was carried out in UV detector at 223 nm.The retention time and total run time was found to be stable at 7.1 min (RT), flow rate1.0 ml, Oven temperature is 25 °C and Injection volume was 20 µl.The developed RP-HPLC method was validated for linearity, accuracy, precision, intraday precision, limit of detection and limit of quantitation as per ICH guideline. Developed method was accurate, precise robust and rugged, it showed % RSD not more than 2%.

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