Original Research Article DOI: 10.18231/2394-2797.2016.0005 International Journal of Pharmaceutical Chemistry and Analysis, 3(4):219-228 219 Development and validation of stability indicating assay method for the estimation of lafutidine and domperidone in capsule dosage form CK Gadewar 1,* , SJ Wadher 2 , SS Pekamwar 3 , SG Gattani 4 1 Research Scholar, 2,3,4 Professor, School of Pharmacy, Nanded *Corresponding Author: Email: ckgadewar@rediffmail.com Abstract A simple, sensitive, precise and specific high performance liquid chromatography method was developed and validated for the determination of Lafutidine and Domperidone in Lafutidine and Domperidone sustained release capsule. The separation was carried out by using a mobile phase consisting Acetonitrile: pH 6.5 phosphate buffer in ratio of 30:70. The column used was Xterra 250mm X 4.6mm, 5μ with flow rate 1 ml/min using UV detection at 276 nm. The retention time of Lafutidine and Domperidone were found to be 7.0 and 15.5 min respectively. Degradation study of Lafutidine and Domperidone in its capsule form was conducted under condition of hydrolysis, oxidation, thermal and photolysis, the results of analysis were validated statistically and by recovery studies (mean recovery = 99.94). The result of study showed that the proposed method is simple, rapid, precise and accurate, which is useful for the routine determination of Lafutidine and Domperidone in pharmaceutical dosage form. Keywords: Lafutidine, Domperidone, Method development, Validation, Forced degradation. Introduction Lafutidine is 2-[(2-furylmethyl)sulfinyl]-N-((2Z)- 4-{[4-(piperidin-1-ylmethyl)pyridin-2-yl]oxy}but-2-en- 1-yl)acetamide (Fig. 1). It is a gastroprotective and antiulcer drug, which selectively block H2 receptors. Physical properties are white crystalline powder, soluble in methanol and freely soluble in glacial acetic acid, stable under ordinary condition. Domperidone is 5-chloro-1-(1-[3-(2-oxo-2,3- dihydro-1Hbenzo[d]imidazol1yl)propyl piperidin-4-yl)- 1H-benzo[d]imidazol2(3H)-one (Fig. 2). It is an antiemetic drug, which selectively block CTZ receptors. Physical properties are white crystalline powder, soluble in 0.1N HCl. This paper describes validated HPLC method for estimation of Lafutidine and Domperidone, a mobile phase consisting Acetonitrile: pH 6.5 phosphate buffer in ratio of 30:70. The column used was Xterra 250mm X 4.6mm, 5μ with flow rate 1 ml/min using UV detection at 276 nm. Fig. 1: Lafutidine Fig. 2: Domperidone Materials and Method Equipments: HPLC equipped with pump, injector and PDA detector Waters 2695, 2996, HPLC equipped with pump, injector and UV detector, Waters 2695, 2487, HPLC equipped with pump, injector and UV detector, Agilent 1200 series, Balance-Sartorius, Mettler Toledo, Photo stability chamber-Newtronic, Oven- Techno Instrument. Materials: Lafutidine standard (Alkem), Capsules were procured from FR&D department. Disodium hydrogen phosphate dehydrate (Merck) Acetonitrile (Merck) Orthophosphoric acid(Merck), MilliQ water, Hydrochloricacid(Merck), Sodium hydroxide(Merck), Column Xterra 250mmX4.6mm,5μ. Preparation of 0.01 M Disodium hydrogen phosphate dihydrate buffer pH 6.5: Dissolve 4.45 gm Disodium hydrogen phosphate dihydrate in to 1000 ml water, mix and adjust pH 6.5 with orthophosphoric acid, Filter through 0.45μ nylon filter, mix and degas. Preparation of mobile phase: Mix above Buffer and Acetonitrile in the ratio of 70:30, mixed and degassed.Use suitable High Performance Liquid Chromatography equipped with following: Column: Xterra 250mm X 4.6mm, 5μ. Flow rate: 1.0 ml/min Wavelength: 276nm Injection volume: 1μl Column oven temperature: 30ºC Sample compartment temp: 25ºC Run time: 30 minutes Diluent: Mobile phase Preparation of standard Solution: Weigh accurately about 20 mg of Lafutidine working standard and 60mg