IJPAR JOURNAL

Reverse phase high performance liquid chromatography method development and validation for estimation of etoricoxib and thiocolchicoside in pure and pharmaceutical dosage form

M. Mallik — 2023-01-28

A new, simple, Accurate, precise, robust and rugged reverse phase-HPLC method was developed for the simultaneous estimation of the Etoricoxib and Thiocolchicoside in pure and pharmaceutical dosage forms. Chromatogram was run through Hypersil C18 (250 mm×4.6 mm, 5μm) particle size. Mobile phase containing Potassium dihydrogen phosphate (0.03M) (pH-2.8): Methanol (75:25%) was pumped through column at a flow rate of 1.0ml/min. Temperature was maintained at Ambient. Optimized wavelength selected was 226 nm. Retention time of Etoricoxib and Thiocolchicoside were found to be 1.693min and 3.235min ± 0.02 respectively. The precision %RSD of the Etoricoxib and Thiocolchicoside were and found to be 0.435 and 0.039 respectively. %Recovery was obtained as 100.06% and 100.083% for Etoricoxib and Thiocolchicoside respectively. Regression equation of Etoricoxib is y = 48138x + 5396.0., and y = 71.91x + 42.07 of Thiocolchicoside. The LOD and LOQ values were found to be for the Etoricoxib and Thiocolchicoside are 1.27µg/ml, 1.16 µg/ml 3.81µg/ml, 3.48µg/ml and the proposed method was found to be simple, precise, accurate, rapid, economic and reproducible for the estimation of Etoricoxib and Thiocolchicoside in pure form and pharmaceutical marketed formulation.

A novel rp-hplc method for the estimation of ivacaftor and tezacaftor in bulk and pharmaceutical dosage formulations

Devikasubramaniyan.G — 2023-01-28

A selective and sensitive reverse phase high performance liquid chromatography (RP-HPLC) has been developed for the separation and quantification of and Ivacaftor and Tezacaftor in tablet dosage form and validated .The determination was carried out using Symmetry C18 column (250 mm ×4.6 mm id) as a stationary phase and mobile phase comprised of Methanol: TEA buffer pH 4.2 (40:60v/v) with pH adjusted to 4.2±0.5 by using Ortho phosphoric acid. The flow rate was 1.0ml/min and the eluent was monitored at 260 nm. The retention time of and Ivacaftor and r were 2.773 ±0.018 min and 4.065±0.024 min respectively. The Coefficient of correlation and percentage recoveries of Ivacaftor and Tezacaftor were 0.9986 and 100.0l % and 0.9994 and 99.98% respectively. The method is validated for accuracy, Precision, ruggedness and Robustness. The proposed method is successfully applied for the simultaneous determination of both drugs in commercial tablet preparation. The results of the analysis have been validated statistically and by recovery studies.

Determination of trametinib in pharmaceutical formulations by rp-hplc method

Devikasubramaniyan.G — 2023-01-30

A new simple, accurate, economic, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trametinib in bulk form and its pharmaceutical dosage form. Chromatographic separation was carried out on Zorbax C18 (4.6mm x 250mm, 5mm, Make: X terra) column using a mixture of Acetonitrile: Methanol: Water (50:30:20% v/v) as the mobile phase at a flow rate of 1.0 ml/min, the detection was carried out at 245nm. The retention time of the Trametinib was found to be 5.462 ±0.02min. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 50-90 mcg/mL for Trametinib. The correlation coefficient was found to be 0.999. The LOD and LOQ for Trametinib were found to be 1.6µg/mL and 4.8µg/mL respectively. The proposed method was found to be good percentage recovery for Trametinib, which indicates that the proposed method is highly accurate. The proposed HPLC conditions ensure sufficient resolution and the precise quantification of the compounds. Results from statistical analysis of the experimental results were indicative of satisfactory precision and reproducibility. Hence the developed method was successfully applied to determine Trametinib in pharmaceutical formulations