ACTA Pharmaceutica Sciencia 2011 , Vol 53 , Num 1
DEVELOPMENT AND VALIDATION OF A HPLC METHOD FOR THE DETERMINATION OF MONTELUKAST AND ITS DEGRADATION PRODUCTS IN PHARMACEUTICAL FORMULATION USING AN EXPERIMENTAL DESIGN
AHMED B ELDİN, ABDALLA A SHALABY, MAHA EL-TOHAMY
Methodology Manager, SIGMA Pharmaceutical Corp., Egypt Simple, sensitive and accurate stability indicating analytical method for montelukast has been developed and validated by using RP-HPLC techniques and applying the proposed method in the assay of Montelukast® tablets (SIGMA Pharmaceuticals), since there is no official monograph. The procedure was developed and validated under acidic, basic, oxidative and photo-irradiation conditions. Chromatography was performed with mobile phase containing a mixture of acetonitrile and 0.01M potassium dihydrogen phosphate buffer pH 4.0 (7:3 v/v) with flow rate of 1.0 mL per min, C18 column and UV detection at 355 nm. developed method satisfies the system suitability criteria, peak integrity, and resolution for the parent drug and its degradants. The method was validated for linearity (correlation coefficient = 0.9999), accuracy, and precision. Experimental design was used for validation of robustness and intermediate precision. The proposed method was simple, highly sensitive, precise and accurate. And the run time was less than 15 min which indicates the method is useful for routine quality control analysis and stability testing. Montelukast was determined to be more sensitive to the acidic conditions and photodegradation on light exposure, oxidation may also appear. But it was stable in alkaline medium. Keywords : HPLC, STABILITY INDICATING METHOD, MONTELUKAST, EXPERIMENTAL DESIGN

Istanbul Medipol University