Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Domperidone and Naproxen in Tablet Dosage Form.

ABSTRACT

A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the simultaneous analysis of domperidone and naproxen in tablet dosage form. The chromatographic system consisted of two LC-20 AT pump, SPD-20A UV detector, SIL-20A auto-sampler and CTO- 10ASVP column oven. Chromatographic separation of drugs was achieved on an Shim-Pack C18 column (250 mm x 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of phosphate buffer (pH adjusted to 3.00 with sodium hydroxide) methanol in the ratio 3070 (v/v) at a flow rate of 1.0 ml/min with UV detection at 280 nm. Retention time was 3.17 minutes for domperidone and 5.42 minutes for naproxen. The method was found selective and peaks of domperidone and naproxen were well separated (resolution 10.72). The proposed method is linear (r2 = 0.999 for domperidone and naproxen), accurate with 99.5% recovery for domperidone and 99.39% recovery for naproxen and precise (%RSD < 1%). The method has been used to determine potency of commercial product and potency was found within limit. The method can be used for the analysis of domperidone and naproxen in tablet dosage form.