Development and Validation of HPLC Method For the Dissolution Analysis in its Dosage Form
HPLC method was deloped and validated for dissolution analysis of Fluvoxamine was carried out at 50rpm and
water as dissolution medium with the help of 8 station , type II dissolution apparatus .The aliquots were removed out after
each 5 min interval for 30 min and their absorbance is measured by doing suitable dilution at 245 nm with the help of UVspectrophotometer.
The chromatographic separation was carried out using column hyperchrom ODS 5 micron C -18
(250×4.6 mm ,100 0 A ) having flow rate 1.0 ml/min using mobile phase methanol : phosphate buffer(70:30 v/v) PH
adjusted to 2.5 with 0.1N HCL the retention time of Fluvoxamine maleate was found to be 5.9 min the linearity of
Fluvoxamine maleate was in the range of 10-50 micro g/ml. The method validation was carried out as per ICH guideline , it
was found that the results obtained by proposed method for tablet formulation containing Fluvoxamine maleate is reliable ,
precise and accurate. Hence it can be routinely adopted for dissolution analysis of said drug in formulation.
Keywords— Fluvoxamine Maleate.