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Volume :

2

Issue :

4

Abstract :

A simple, rapid and precise liquid chromatographic method for simultaneous determination of isoniazid thiacetazone and pyridoxine, in a tablet dosage form has been developed. Chromatographic analysis was performed on a HYPERSIL ODS column (C18) column (150*4.6 mm) of 5µ particle size, applying isocratic elution with a mobile phase. A mixture of 40 volumes of Ammonium Formate Buffer: 60 volumes of Acetonitrile were prepared. The mobile phase was sonicated for 10min to remove gases Wave length: 254nm Injection volume:20µl Column temperature: 25o C. UV detection was performed at 254 nm. The total run time was 8 min. Retention times for isoniazid thiacetazone and pyridoxine are 2.7428, 3.6267, 8.217 mins, respectively. The method was validated with respect to linearity, accuracy, precision, specificity and sensitivity in accordance with ICH guidelines. The percent recovery for Isoniazide is 99.99%, Thiacetazone 99.14% and Pyridoxine 99.4%. The linearity was determined at five levels over the range of 50%-150% of standard concentration in diluents. The concentration range at which linearity was established is 200-600 g/ml for Isoniazide Thiacetazone 100-300 and Pyridoxine 2-6g/ml. The coefficient of correlation (R2 = 0.998) for Isoniazide, and Thiacetazone for (R2 = 0.997) and (R2= 0.996) for Pyridoxine. The plate count was found to be more than 2000, tailing for the same peak is not more than 2.0 and % RSD is not more than 2.0%. High recovery and low coefficients of variance confirmed the suitability of the method for the simultaneous analysis of the three considered drugs. Isoniazide, Thiacetazone and Pyridoxine was subjected to various stress conditions like hydrolytic degradation, thermal degradation, Peroxide degradation, photolytic degradation. The developed method was found to be stable in all the conditions. The developed method is stability indicating and can be used or routine analysis of Isoniazide, Thiacetazone and Pyridoxine free of interference from their degradation products in suspension formulation.