1Pharmaceutical Analysis and Quality Assurance Department, MAEER's Maharashtra Institute of Pharmacy, MIT Campus, Paud Road, Kothrud, Pune, 411038, Maharashtra, India
2R & D Department, Emcure Pharmaceuticals Ltd. Bhosari, Pune. 411026, Maharashtra, India
3Department of Pharmacy, Prist University, Thanjavur, 614904, Tamil Nadu, India
*Corresponding Author E-mail: swagatim@gmail.com
Online published on 7 February, 2013.
A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the simultaneous analysis of Lafutidine and Domperidone Maleate in tablet dosage form.Chromatographic separation of drugs was achieved on Hypersil BDS C8 column (250 mm x 4.6 mm, 5 μ) as stationary phase with a mobile phase comprising of phosphate buffer (pH adjusted to 4.5 with orthophosphoric acid):Methanol:Acetonitrile in the ratio 55:25:20 (v/v/v) at a flow rate of 1.0 mL/min with UV detection at 222 nm. Retention time was 4.07 minutes for Lafutidine and 6.13 minutes for domperidone. The method was found selective and peaks of Lafutidine and Domperidone were well separated (resolution 9.82). The proposed method is linear (R2 = 0.999 for both Lafutidine and Domperidone), accurate with 99.45–100.08% recovery for Lafutidine and 99.20100.12% recovery for Domperidone and precise (%RSD < 2%). 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 Lafutidine and Domperidone in tablet dosage form.
Domperidone Maleate, Lafutidine, Validation, RP-HPLC
