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

[摘要] 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 (4.5×100 nm) 5.0 µm, flow rate was 1 mL/min, mobile phase ratio was 70:30 v/v methanol:sodium acetate buffer. A pH of 3 was adjusted with Ortho phosphoric acid, wavelength was detected at 240 nm. Column dimensions were Thermosil C18(4.6×100mm) 5.0 µm.Results: The results were in good agreement with those obtained with official HPLC with absorption maximum at 240 nm by preparing mobile phase 70:30 methanol:sodium acetate buffer with a flow rate 1 mL/min and it ran for 5 minutes by selecting thermosil RPC18 (4.5×100 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 (4.5×100 nm) 5.0 µm, flow rate was 1 mL/min. Both the samples were in the range of 200 to 400 nm and maximum wavelength was identified at 240 nm. 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 (4.5×100 nm) 5.0 µm, flow rate was 1 mL/min, mobile phase ratio was 70:30 v/v methanol:sodium acetate buffer. A pH of 3 was adjusted with Ortho phosphoric acid, wavelength was detected at 240 nm. Column dimensions were Thermosil C18(4.6×100mm) 5.0 µm.Results: The results were in good agreement with those obtained with official HPLC with absorption maximum at 240 nm by preparing mobile phase 70:30 methanol:sodium acetate buffer with a flow rate 1 mL/min and it ran for 5 minutes by selecting thermosil RPC18 (4.5×100 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 (4.5×100 nm) 5.0 µm, flow rate was 1 mL/min. Both the samples were in the range of 200 to 400 nm and maximum wavelength was identified at 240 nm.

[学科分类] 药学、药理学、毒理学（综合）

[关键词] Thermosil C18 column;Rifampicin;Isoniazid;RP-HPLC