Abstract
A simple, rapid, sensitive, cost effective, and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the stability testing of rufinamide. The proposed RP-HPLC method was developed on phenome-nex LunaR C-18 5μm,250 mm × 4.6 mm id. Column (at ambient temperature) and a mobile phase consisting of phosphate buffer: acetonitrile (60:40) was delivered at a flow rate of 1.0ml/ min. The analyte was detected by using a UV detector at the wavelength of 293 nm. The method was found to be linear over the concentration range of 50- 150 μgml-1 (r2=0.999). 30. The retention time of rufinamide was 4.717 min.
Highlights
Stability testing forms an important part in the process of drug product development
The purpose of stability testing is to Journal of Pharmaceutical provide evidence on how the quality of drug substance varies with time under Technology, Research and the influence of variety of environmental factors such as temperature, humidity
Number of methods are available to carryout stability indicating assay e.g. gas chromatography and nuclear magnetic resonance (NMR) (Chatwal, G., Anand, S.K., 2004 and Riley, M., Rosanke, T.W., 1996)
Summary
Stability testing forms an important part in the process of drug product development. Active pharmaceutical ingredient (API) is the important part of drug formulation and drug degrades with time so there is a need to develop methods which can detect degradation as well as degraded products (Chafez, L., 1971 and Sethi, P.D., 2001). The purpose of stability testing is to Journal of Pharmaceutical provide evidence on how the quality of drug substance varies with time under Technology, Research and the influence of variety of environmental factors such as temperature, humidity. Management Volume 1, No 2, and light which enables recommendation of storage conditions, retest periods. Values 238.19 White crystalline powder 237 - 2400 C Very low Soluble in water and soluble in THF and methanol Stable under ordinary conditions. Values 238.19 White crystalline powder 237 - 2400 C Very low Soluble in water and soluble in THF and methanol Stable under ordinary conditions. 98.5% 0.15% max 9.5-12.5% max -0.820 ≥ 20 ppm Anti-epileptic Drug Solid 6-10 hours
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