Theoretically Guided Analytical Method Development and Validation for the Estimation of Rifampicin in a Mixture of Isoniazid and Pyrazinamide by UV Spectrophotometer

Abstract

A simple, rapid, economic, accurate, and precise method for the estimation of rifampicin in a mixture of isoniazid and pyrazinamide by UV spectrophotometeric technique (guided by the theoretical investigation of physicochemical properties) was developed and validated. Theoretical investigations revealed that isoniazid and pyrazinamide both were freely soluble in water and slightly soluble in ethyl acetate whereas rifampicin was practically insoluble in water but freely soluble in ethyl acetate. This indicates that ethyl acetate is an effective solvent for the extraction of rifampicin from a water mixture of isoniazid and pyrazinamide. Computational study indicated that pH range of 6.0–8.0 would favor the extraction of rifampicin. Rifampicin is separated from isoniazid and pyrazinamide at pH 7.4 ± 0.1 by extracting with ethyl acetate. The ethyl acetate was then analyzed at λmax of 344.0 nm. The developed method was validated for linearity, accuracy and precision according to ICH guidelines. The proposed method exhibited good linearity over the concentration range of 2.5–35.0 μg/mL. The intraday and inter-day precision in terms of % RSD ranged from 1.09 to 1.70% and 1.63 to 2.99%, respectively. The accuracy (in terms of recovery) of the method varied from of 96.7 ± 0.9 to 101.1 ± 0.4%. The LOD and LOQ were found to be 0.83 and 2.52 μg/mL, respectively. In addition, the developed method was successfully applied to determine rifampicin combination (isoniazid and pyrazinamide) brands available in Bangladesh.

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“…This finding is in agreement to Rodrigues et al, who mentioned that partially ionized (~40%) of rifampicin at pH 7.4 leads to an increase of solubility. 54 , 55 From these results, higher rifampicin release percentage at pH 7.4 was demonstrated by the feasibility of potential drug delivery in macrophage compartments which was more compatible against cell invaded S. aureus . The inhibition of autophagosome maturing could allow S. aureus to escape to the cytoplasm and lead to the death of the host cell.…”

State of the Art on Developments of (Bio)Sensors and Analytical Methods for Rifamycin Antibiotics Determination

“…A RIF assessment from its mixture with ISN and PYR was based on the fact that RIF is soluble in ethyl acetate and not soluble in water, while the solubility of the other two analytes is reversed. Therefore, after extraction in ethyl acetate, RIF was determined by simple absorbance measurements at 334 nm [ 136 ]. RIF was quantified from wastewater samples using the standard addition method and the absorbancies measured at 338 nm, after cloud point extraction in the presence of the surfactant Triton X-100 [ 137 ].…”

Chemometric-Assisted UV-Spectrophotometric Method for Quantification of Novel Anti-Tubercular Liquisolid Formulation

“…Quercetin has appeared to build bioavailability, blood levels and adequacy of various medications, including diltiazem, digoxin, verapamil, etoposide, and paclitaxel [13][14][15]. According to the literature, numerous methods, including UV spectroscopy [16,17], RP-HPLC [18][19][20], HPTLC [21,22] and others, are available for determining RIF both alone and in conjunction with various drugs in a variety of dose forms. A few methods, including HPLC [23][24][25][26], UV spectroscopy [27] and HPTLC [28][29][30][31], have been taken into consideration for the assessment of QUE both alone and in conjunction with different drugs in different forms of dosage.…”