A. Chavhan1, J.P. Ambhore2, S. A. Shinde3, A. N. Ugale4
1,2,3Dr. Rajendra Gode College of Pharmacy, Malkapur Dist- Buldana (MS) – 443101
4Government College of Pharmacy, Kathoranaka, Amravati Dist- Amaravati (MS)-444604
A B S T R A C T
A new stability indicating reversed-phase high performance liquid chromatography method was developed for assay of Domperidone and Pantoprazolein tablet. The separation was achieved on column (4.6 × 250mm, 5μm) using methanol and water (60:40, v/v) as mobile phase for assay and flow rate 0.7ml/min. Detection was carried out in U.V detector at 285.0 nm. The retention time of4.36min approximately for Domperidone and Pantoprazole. The systemsuitability test shows the response with retention time, theoretical plate,tailing factor and peak area for both the drugs. The force degradation study was carried out by acid, alkali, peroxide and neutral at RT and the % degradation was 5.45% by acid5.50% by base6.24% by peroxide. The validation of method carried out using ICH guidelines. The developed method was accurate, precise, economic, fast, and selective for simultaneous determination of Domperidone and Pantoprazolein combined tablet formulation. The method gave good resolution for drugs.
Keywords: Domperidone, Pantoprazole, reversed phase high performance liquid chromatography, Stability-indicating method.