Saturday , 20 April 2024

Analytical Method Development and Validation by RP-HPLC for Simultaneous Estimation of Isoniazid and Ethambutol in Combined Tablet Dosage Form

Gampa Vijaya Kumar1*, N. Rajendra Prasad2
1Professor, Departmernt of Pharmaceutical Analysis, CVM College of Pharmacy, Velichala, Kothapally, Karimnagar, Telangana-505451
2Asst. Professor, Departmernt of Pharmaceutical Analysis, CVM College of Pharmacy, Velichala, Kothapally, Karimnagar, Telangana-505451

A B S T R A C T
A simple, Accurate, precise method was developed for the simultaneous estimation of the Isoniazid and Ethambutol in Tablet dosage form. Chromatogram was run through Inertsil ODS C185mm (4.6 x 250mm). Mobile phase containing Phosphate buffer and Acetonitril  in the ratio of 30:70 was pumped through column at a flow rate of 1ml/min. Buffer used at pH 4.6. Temperature was maintained at Ambient. Optimized wavelength for Isoniazid and Ethambutol was 255n. Retention time of Isoniazid and Ethambutol were found to be 2.399min and 3.907min. The % purity of Isoniazid and Ethambutol was found to be 100.7% and 101.4% respectively. The system suitability parameters for Isoniazid and Ethambutol such as theoretical plates and tailing factor were found to be 1.3, 5117.5and 1.4, 3877.3 the resolution was found to be 8.0.The linearity study for Isoniazid and Ethambutol was found   in   concentration   range   of   1μg-5μg   and   100μg-500μg   and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively.  The precision study was precise, robust and repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively.
Keywords: Lopinavir, Ritonavir, RP-HPLC

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