Abstract
Design of Experiment assisted stability indicating RP-HPLC wasdesigned, developed and optimized using response surface methodology for simultaneous determination of Montelukast sodium and Rupatadine fumarate. Separation was achieved using Acetonitrile: Phosphate buffer (75:25) v/v with pH adjusted to 4.0, flow rate of 1 ml/min with UV detection at 246 nm on RP-C18 column. Stress degradation studies were performed as per scientific guidelines. Method was validated in accordance with regulatory requirements. Results obtained in validation were found to be within specified limit. Montelukast was eluted at 3.99 min and Rupatadine was eluted at 13.25 min respectively. All stress degradation products are very well resolved from drug peak which indicate suitability indicating nature of the developed method. Design of Experiment technique can help in fast and economical optimization of mobile phase which in turn will save time for method development. The developed method is, accurate, sensitive which can be utilized as stability indicating method for identification of degradation products in routine analysis of the drug.
Highlights
IntroductionRupatadine Fumarate is an Anti-allergic, antihistaminic molecule chemically it is 8-Chloro-
2.1 Instrument and SoftwareRupatadine Fumarate is an Anti-allergic, antihistaminic molecule chemically it is 8-Chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene]-5Hbenzo[5,6]cyclohepta[1,2-b]pyridine fumarate
Gift samples of Montelukast Sodium and Rupatadine Fumarate were supplied by local pharmaceutical industries
Summary
Rupatadine Fumarate is an Anti-allergic, antihistaminic molecule chemically it is 8-Chloro-. R-(E)-1-[1-[3-[2-(7-chloro-2-quinolinyl) ethenylphenyl]-3-[2(1-hydroxy-1-methylethyl) phenylpropyl thiomethyl cyclopropane acetic acid, and is available in monosodium salt form.Both drugs are used in combination for the treatment of asthma and as anti-allergic [1,2]. Carry-500 Double beam UV-Visible spectrophotometer (Varian) with CARRY software, HPLC Systemhaving 515-pumps with column oven, PDA detectors Auto sampler (Waters) with Empower 2.0 software and pH Meter (Equiptronics) were used for method development. Along with this Design Expert 7.0 (Trial Version)was used for designing and optimizing the method parameters.
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