Stability indicating HPTLC method development and validation for simultaneous analysis of Levodropropizine and Chlorpheniramine Maleate in syrup formulation

Abstract We report herein, an accurate, precise, specific and robust high-performance thin layer chromatographic technique along with forced degradation testing was established and validated for analysis of Levodropropizine and Chlorpheniramine Maleate in pharmaceutical formulation. Robustness study was conducted by using fractional factorial design. The 2 4–1 design examined at both high level (+1) and low level (-1). Four factors were selected in the design matrix which includes chamber saturation time, solvent front, wavelength, and methanol volume in mobile phase. Base, acid, oxidation, dry heat, and photodegradation tests were performed on both medications. The developed technique employed silica gel (60 F 254 ) as a stationary component and Triethylamine: Toluene: Methanol (0.5:3:16 v/v/v) as the mobile phase mixture. A densitometric investigation conducted at 270 nm showed a strong, symmetrical peak for Chlorpheniramine maleate and Levodropropizine, with R f values of 0.59 and 0.39, respectively. The ICH Q2(R2) recommendation was implemented in the validation of the procedure. For Levodropropizine and Chlorpheniramine maleate, the calibration curve regression coefficients were determined to be 0.9959 and 0.9943 in the range of concentrations of 1500–7500 and 100–500 ng/band, respectively. The technique had a correctness of 97.07% for Levodropropizine and 96.12% for Chlorpheniramine Maleate, respectively. In Robustness study methanol volume in mobile phase, chamber saturation time and wavelength have minor effect on response of R f value. Levodropropizine and Chlorpheniramine Maleate are susceptible to chemical oxidation, photolytic study, base hydrolysis, and dry heat degradation while both the drugs have less degradation in wet heat and acid hydrolysis.