Development and validation of RP-HPLC method for simultaneous estimation of tizanidine hcl and meloxicam in bilayer mucoadhesive buccal films

Abstract

Tizanidine HCl (TZN HCl) is a muscle relaxant and Meloxicam (MLX) is a non-steroidal antiinflammatory drug used for various pain disorders. They are extensively used as combination therapy in various pain disorder and the need is to develop a suitable method for their simultaneous determination loaded in a single dosage form. The objective of the study was to develop a simple, specific, and accurate reverse phase high performance liquid chromatographic (RP-HPLC). Method was developed for the simultaneous determination of TZN HCl and MLX. A kromasil C18 (250 × 4.60 mm dimensions, 5 μm particle size) column with a mobile phase consisting of methanol : water (80 : 20) was used at isocratic mode. pH of the mobile phase was adjusted to 3.0 by using orthophosphoric acid and 228 nm was taken as lambda max for the detection of drugs. Flow rate was adjusted to 0.8 mL/min at ambient temperature with an average operating pressure of 140 bar. The retention time of TZN HCl was 2.613 min and of MLX was 6.992 min with a resolution of 3.23 and both drugs showed satisfactory linearity in the range of 5-50 μg/mL with a correlation coefficient (R2) 0.09997 and 0.9993 respectively. The method was validated as per ICH guidelines and found to be prEcised with less than 2% relative standard deviation (%RSD). % Recoveries of TZN HCl and MLX were in the range of 99.01% to 100.47% and 98.18% to 100.88% respectively. From the result, it was concluded that the method is suitable for the simultaneous quantification of TZN HCl and MLX.