Prospective Study Method Development and Validation of Flupentixol and Melitracen in Pure API and Combined Dosage Form by RP-HPLC

P.Haritha¹, Sravanthi Bodike², Gampa Vijay Kumar^3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
²KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
³Professor and Head, Dept.of Pharmacy, KGR InstituteofTechnology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Flupentixol and Melitracen was done by RP-HPLC. The Phosphate buffer was p^H 4.5 and the mobile phase was optimized with consists of ACN: Phosphate buffer mixed in the ratio of 80:20 % v/v. Kromosil C₁₈  Column (250mm x 4.6mm)5µg or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 252 nm. The solutions were chromatographed at a constant flow rate of 0.8ml min^-1. The linearity range of Flupentixol and Melitracen were found to be from 100-500 mg/ml of Flupentixol and 1-5mg/ml of Melitracen. Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Flupentixol and Melitracen. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
Keywords: Kromosil C_18, Flupentixol and Melitracen, RP HPLC