Analytical Method Development and Validation for the Simultaneous Estimation of Rifampicin and Isoniazid in its Bulk and Pharmaceutical Dosage Forms by RP-HPLC

Abstract

Background A combination of Rifampicin and Isoniazid is the drug of choice to treat tuberculosis patients in sustenance or those travelling to a region where there is a probability of being infected with tuberculosis.Objective The main objective of the simultaneous estimation of combined drug was to establish identity purity physical characteristics and potency of the drugs.Methodology The chromatographic environment was fortunately evolved for the partition of Rifampicin and Isoniazid by using column thermosil RPC18 4.5times100 nm 5.0 microm flow rate was 1 mLmin mobile phase ratio was 7030 vv methanolsodium acetate buffer. A pH of 3 was adjusted with Ortho phosphoric acid wavelength was detected at 240 nm. Column dimensions were Thermosil C184.6times100mm 5.0 microm.Results The results were in good agreement with those obtained with official HPLC with absorption maximum at 240 nm by preparing mobile phase 7030 methanolsodium acetate buffer with a flow rate 1 mLmin and it ran for 5 minutes by selecting thermosil RPC18 4.5times100 nm of ambient temperature. All the results obtained were precise accurate and robust as per international conference on Harmonization ICH guidelines.Conclusion It can be concluded that the proposed Reverse Phase High Performance Liquid Chromatographic RPHPLC method is accurate precise sensitive specific robust and reproducible for the simultaneous analysis of Rifampicin and Isoniazid with less tailing factor and is also economical. Thermosil RPC18 4.5times100 nm 5.0 microm flow rate was 1 mLmin. Both the samples were in the range of 200 to 400 nm and maximum wavelength was identified at 240 nm.