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ABSTRACT:
A simple, precise, accurate High-performance thin-layer chromatography (HPTLC) method has been developed and validated for the estimation of escitalopram oxalate (ESC) and flupentixol dihydrochloride (FLU) in pharmaceutical formulation. Separation was achieved on an aluminum HPTLC plate coated with a 0.2 mm layer of silica gel 60 F254 with chloroform: methanol 4:6 (v/v) as mobile phase. The densitometry analysis was carried out in absorbance mode at 254 nm. The Rf values of escitalopram and flupentixol were 0.24 and 0.44 respectively. The linearity of the method was achieved in the range 3-7 pg/spot for ESC with correlation coefficient value 0.998 and 0.3-0.7pg/spot for FLU with correlation coefficient value 0.999. The developed method was validated according to ICH guidelines and the results were statistically validated. The limit of detection and quantification for escitalopram oxalate and flupentixol dihydrochloride was found to be 500 ng/spot and 50 ng/spot, 1000 ng/spot, and 100 ng/spot respectively.
KEYWORDS: Escitalopram oxalate, Flupentixol dihydrochloride, HPTLC, Validation, ICH.
INTRODUCTION:
Escitalopram oxalate (ESC) is an antidepressant drug belonging to the category of selective serotonin reuptake inhibitors (SSRI). It acts by inhibiting sodium dependent serotonin transporter thereby blocking the reuptake of serotonin and making it available in the brain. It also acts as an antagonist of the histamine H1 receptor. Chemically it is (S)1-3[3-(dimethylamino) propyl]-1-(4fluorophenyl)-1, 3-dihydro-5-iso benzofuran 5 carbonitrile oxalate; official in Indian Pharmacopeia1. It is used as the first-line drug in depression and also used in the treatment of other psychiatry disorders like anxiety, phobia, obsessive-compulsive disorder (OCD), and eating disorders like Bulimia nervosa. It improves the feeling of well-being, increases energy levels, and decreases the nervousness of patients. Flupentixol dihydrochloride (FLU) is an antipsychotic drug, belonging to the category of thioxanthenes. It acts as strong antagonists of D1 and D2 dopamine receptors and also antagonizes alpha-adrenergic receptors and serotonin receptors.
Chemically, it is (z)-4-[3-(2-(trifluoromethyl)-9H thioxanthene-9-ylidene] propel]-1-piperazine ethanol dihydrochloride. It is official in British pharmacopoeia2. It is highly water and methanol soluble. It is primarily used in schizophrenia mainly in people with poor compliance to medications and with frequent relapses, since it is a long-acting drug it is given through an injection route once every two to three weeks, thus improving compliance and preventing relapses in Schizophrenia patients. A Combination of ESC and FLU is...