Volume 8 No. 1, 2018
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Insight Pharmaceutical Sciences>>  Volume 8 Issue 1, 2018
Stability-indicating UV-spectrophotometric Assay of Rifampicin
Nagaraju Swamy , Kanakapura Basavaiah and Penmatsa Vamsikrishna
Abstract: Background: Rifampicin (RIF), chemically known as 3-[[(4-methyl-1-piperazinyl)-imino]-methyl]-rifamycin SV is potentially hepatoxic and is an established first-line antituberculosis agent derived from rifamycin SV and its use in other serious infections, such as HIV is increasing. Objective: Two simple, sensitive, precise and economical UV-spectrophotometric methods were developed and validated for the determination of rifampicin (RIF) in bulk drug, capsule formulation and spiked human urine. Materials and Methods: The methods are based on the measurement of absorbance of RIF either in 0.1 M hydrochloric acid (HCl) at 263 nm (method A) or in 0.1 M orthophosphoric acid (H3PO4) at 259 nm (method B). Results: The methods were validated for linearity, accuracy and precision, limits of detection (LOD) and quantification (LOQ) and robustness and ruggedness as per the current ICH guidelines. Beer’s law was obeyed over concentration range of 1.5-30 μg mL–1 RIF in both methods with correlation coefficients of 0.9995 and 0.9997 for method A and method B, respectively. The corresponding molar absorptivity values were 2.49×104 and 2.71×104 L mol–1 cm–1. The utility of the methods was tested by their application to marketed formulation and the relative error and relative standard deviations were less than 2.1%. The validity and reliability of the proposed methods were further ascertained by the recovery studies via standard addition technique. In addition, forced degradation of RIF was conducted in accordance with the ICH guidelines. Acidic, basic, thermal, peroxide and photolytic stress conditions were used to assess the stability-indicating potency of the methods. Conclusion: Very slight degradation under peroxide-induced, slight degradation under acid-induced and substantial degradation under base-induced stress conditions were observed in both methods. No degradation was observed under other stress conditions. To enhance their usefulness, the methods were successfully applied to the determination of RIF in spiked human urine with satisfactory recovery.
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    How to Cite:
Nagaraju Swamy, Kanakapura Basavaiah and Penmatsa Vamsikrishna , 2018. Stability-indicating UV-spectrophotometric Assay of Rifampicin. Insight Pharmaceutical Sciences, 8: 1-12
DOI: 10.5567/IPHARMA-IK.2018.1.12
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