Validating an hplc method

Samples were prepared with methanol and the volume injected was 20 μL.The analytical curve was linear (r² 0.9995) over a wide concentration range (2.0-30.0 μg.m L-1).

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RP-HPLC was performed on a Waters C18, 5 µm particle size, 25 cm × 4.6 mm i.d., with phosphate buffer and acetonitrile in the ratio of v/v as a mobile phase and a flow rate of 1.0 ml min-1. Validation of the developed method was done as per USP and ICH guidelines.

Limit of detection were 0.02 µg/ml and limit of quantification were 0.06 µg/ml for Dapagliflozin.

The high recovery and low coefficients of variation confirm the effectiveness of process in the dosage form.

The isocratic mobile phase was methanol:water (; v/v) at a flow rate of at 1.0 m L.min-1.

The determinations were performed using UV-Vis detector set at 239 nm.


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