Development and validation of a RP-HPLC method for simultaneous estimation of antitubercular drugs in solid lipid nanoparticles

Abstract

A new simple, rapid and sensitive reversed-phase high-performance liquid chromatography method was developed and validated as per International Conference on Harmonization guidelines, Q2 (R1), for simultaneous estimation of isoniazid, pyrazinamide and rifampicin in solid lipid nanoparticles. Separation was achieved on a 250×4.6 mm, 5 μm, C-18 column using a linear gradient flow rate of 1.5 ml/min. Isoniazid, pyrazinamide and rifampicin were identified based on their retention times as compared to standards and confirmed with characteristic spectra on a spectrophotometer at 238 nm and eluted at 3.787, 4.173 and 11.273 min, respectively, achieved within 20 min. This method was linear, precise with % RSD values of 0.18 % for isoniazid, 0.15 % for pyrazinamide and 0.47 % for rifampicin, accurate with mean recovery yields of 101.312 % for isoniazid, 99.910 % for pyrazinamide and 99.767 % for rifampicin and selective over the concentration range of 10-150 % for all the three drugs. This method is suitable due to its simplicity and accuracy for routine quality control and stability analysis of antitubercular drugs-loaded solid lipid nanoparticles.