Simultaneous Quantification of Cephalexin and Sodium Benzoate in their Dosage forms by high analytical technique. Application of Lean Six Sigma and In-Vitro Dissolution studies

Objectives. - The aim of the present work is to develop and validate a novel and simple Chromatographic and MCR methods for simultaneous quantification of cephalexin (CPH) and sodium benzoate (SDM) in their dosage form and application of Lean Six Sigma (LSS) to reduce variation and improve quality. Methods. - Isocratic separation is performed using Agilent XDB-C8 (4.6 mm x 250 mm) 5 mu m, with a mobile phase consisting of acetonitrile: water (30: 70, v/v) containing 0.1% orthophosphoric acid (OPA) at flow rate of 1.5 mL/min and wavelength 254 nm with injection volume of 20 mu L for HPLC and Agilent ZORBAX SB-C18 column (50 mm x 2.1 mm, 1.8 mu m particle size) at flow rate 0.25 mL/min, injection volume 0.8 mu L for UPLC. MCR spectrophotometric method is successfully applied for resolving spectral overlap of drugs at 240 nm and 250 nm for CPH and SDM, respectively. Comparative invitro dissolution studies are established on Generic product; Rivalexin and Lexin 250 mg/5 mL, consequently it had been considered equivalent and like the innovator product; Cephalexin USP 250 mg/5 mL using different USP media. Results. - Good Linearity and recovery are achieved over the concentration range of 10-300, and 5-50 mu g/mL for the studied drugs. Process Capability Index (Cpk) is > 1.33 and still capable during all stages of the product release. Conclusion. - The proposed method is accurate and could be applied to dosage form and LSS to interpret the data of quality attributes. (C) 2020 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.