Author(s): Prachi Rajesh Patil, Javesh K. Patil

Email(s): prachirpatil2323@gmail.com

DOI: 10.52711/2231-5675.2026.00048   

Address: Prachi Rajesh Patil*, Javesh K. Patil
Dept. of Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy, Shahada - 425409, Dist. Nandurbar, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 4,     Year - 2026


ABSTRACT:
Rifampicin is a first-line anti-tubercular drug widely used in the treatment of tuberculosis and other bacterial infections. Its therapeutic efficacy is closely linked to accurate quantification in pharmaceutical formulations and biological matrices, necessitating the use of reliable analytical methods. This review provides a comprehensive overview of Rifampicin with particular emphasis on its mechanism of action and the analytical techniques employed for its determination. Various spectroscopic and chromatographic methods, including UV–visible spectroscopy, high-performance liquid chromatography (HPLC), liquid chromatography–mass spectrometry (LC–MS/MS), and high-performance thin-layer chromatography (HPTLC), are critically discussed. The review highlights the principles, advantages, limitations, and validation parameters of these techniques, such as specificity, sensitivity, accuracy, and robustness. Additionally, the importance of stability-indicating methods and regulatory considerations in ensuring drug quality and safety is addressed. By integrating pharmacological aspects with modern analytical advancements, this article serves as a valuable resource for researchers, analysts, and regulatory professionals involved in the development, validation, and quality control of Rifampicin. Ultimately, the study supports ongoing efforts to enhance pharmaceutical analysis and improve therapeutic outcomes in the management of infectious diseases.


Cite this article:
Prachi Rajesh Patil, Javesh K. Patil. A Comprehensive Review on Analytical Strategies for the Determination of Rifampicin in Single Dosage Forms. Asian Journal of Pharmaceutical Analysis. 2026; 16(4):311-7. doi: 10.52711/2231-5675.2026.00048

Cite(Electronic):
Prachi Rajesh Patil, Javesh K. Patil. A Comprehensive Review on Analytical Strategies for the Determination of Rifampicin in Single Dosage Forms. Asian Journal of Pharmaceutical Analysis. 2026; 16(4):311-7. doi: 10.52711/2231-5675.2026.00048   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-4-10


REFERENCES:
1.    Khadka, P., Dummer, J., Hill, P.C., Katare, R., Das, S.C. A review of formulations and preclinical studies of inhaled rifampicin for its clinical translation. Drug Delivery and Translational Research. 2022; 13(5): 1246–1271. https://doi.org/10.1007/s13346-022-01238-y⁠
2.    Onorato, L., Gentile, V., Russo, A., Di Caprio, G., Alessio, L., Chiodini, P., Coppola, N. Standard versus high dose of rifampicin in the treatment of pulmonary tuberculosis: a systematic review and meta-analysis. Clinical Microbiology and Infection. 2021; 27(11): 1614–1620.https://doi.org/10.1016/j.cmi.2021.03.031
3.    Nijland, H.M.J., Ruslami, R., Stalenhoef, J.E., Nelwan, E.J., Alisjahbana, B., Nelwan, R.H.H., van der Ven, A.J.A.M., Danusantoso, H., Aarnoutse, R.E., van Crevel, R. Exposure to rifampicin is strongly reduced in patients with tuberculosis and type 2 diabetes. Clinical Infectious Diseases.  43(7): 848–854.https://doi.org/10.1086/507543⁠m
4.    Van Ingen, J., Aarnoutse, R.E., Donald, P.R., Diacon, A.H., Dawson, R., van Balen, G.P., Gillespie, S.H., Boeree, M.J. Why do we use 600 mg of Rifampicin in tuberculosis treatment? Clinical Infectious Diseases. 52(9): e194–e199. https://doi.org/10.1093/cid/cir184
5.    Rana, F. Rifampicin – An overview. International Journal of Pharmaceutical Sciences Review and Research. 3(2): 1–5. file:///D:/New%20folder/5.pdf
6.    Hardie, K.R., Fenn, S.J.JMM profile: rifampicin: a broad-spectrum antibiotic. Journal of Medical Microbiology. 71(8): Article 001566. https://doi.org/10.1099/jmm.0.001566⁠
7.    Campbell, E. A., Korzheva, N., Mustaev, A., Murakami, K., Nair, S., Goldfarb, A., &Darst, S. A. Structural mechanism for rifampicin inhibition of bacterial RNA polymerase. Cell. 2001; 104(6): 901–912. https://doi.org/10.1016/S0092-8674(01)00286-0
8.    Siddiqui, M.R., Al Othman, Z.A., Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of Chemistry. 2013; 10(2): S1409–S1421. https://doi.org/10.1016/j.arabjc.2013.04.016
9.    Verma G. and Dr. Mishra M.; Development and Optimization of UV-Vis Spectroscopy-A Review. World Journal of Pharmaceutical Research. 2018; 7(11): 1170-118
10.    Jacqueline M.R. Belanger J.R. Jocelyn Pare and Michel Sigouin, High-Performance Liquid Chromatography (HPLC): Principle and Application. 1997: 38-58
11.    Sharma, M.C., Sharma, S., Kohli, D.V. Development and validation of HPTLC method for simultaneous estimation of rifampicin and isoniazid in combined dosage form. Journal of Planar Chromatography – Modern TLC.  23(1): 45–50. https://doi.org/10.1556/JPC.23.2010.1.8.
12.    Song, S.H., Jun, S.H., Park, K.U., Yoon, Y., Song, J. Simultaneous quantification of first-line anti-tuberculosis drugs including rifampicin in human plasma by LC–MS/MS. Journal of Chromatography B.  919–920. https://doi.org/10.1016/j.jchromb.2013.01.011⁠
13.    Dracinsky, M., Bour, P. Structural analysis of rifampicin by NMR spectroscopy and computational methods. Journal of Physical Chemistry B.  115(8): 1952–1960. https://doi.org/10.1021/jp110123k⁠Verma, R.K., Garg, S. Compatibility studies of rifampicin with pharmaceutical excipients using FTIR spectroscopy. Drug Development and Industrial Pharmacy.  27(7): 695–700. https://doi.org/10.1081/DDC-100105183
14.    Verma, R.K., Garg, S. Compatibility studies of rifampicin with pharmaceutical excipients using FTIR spectroscopy. Drug Development and Industrial Pharmacy.  27(7): 695–700. https://doi.org/10.1081/DDC-100105183.
15.    Verma, R.K., Garg, S. Compatibility studies of rifampicin with pharmaceutical excipients using FTIR spectroscopy. Drug Development and Industrial Pharmacy. 27(7): 695–700.
16.    Mohammad F. Khan, Shamima A. Rita, Md. Shahidulla Kayser, Theoretically Guided Analytical Method Development and Validation for the Estimation of Rifampicin in a Mixture of Isoniazid and Pyrazinamide by UV Spectrophotometer. 2017; 5: 1-12, doi: 10.3389/fchem.2017.00027
17.    Chellini, P.R., Lages, E.B., Franco, P.H.C., Nogueira, F.H.A., César, I.C., Pianetti, G.A. Development and validation of an HPLC method for simultaneous determination of rifampicin, isoniazid, pyrazinamide, and ethambutol hydrochloride in pharmaceutical formulations. Journal of AOAC International.  98(5): 1234–1240.DOI: 10.5740/jaoacint.15-0123
18.    Patel, F., Kotadiya, R., Patel, R., Patel, M. Development and validation of a new reversed phase HPLC method for the quantitation of azithromycin and rifampicin in a capsule formulation. Journal of AOAC International. 98(5): 1234–1240.DOI: 10.5740/jaoacint.15-0123
19.    Shah, U., Jasani, A. UV spectrophotometric and RP-HPLC methods for simultaneous estimation of isoniazid, rifampicin and piperine in pharmaceutical dosage form. International Journal of Pharmaceutical Sciences and Research. 5(11): 4800–4806.DOI: 10.13040/IJPSR.0975-8232.5(11).4800-06
20.    Khan, M.F., Rita, S.A., Kayser, M.S., Islam, M.S., Asad, S., Rashid, R.B., Bari, M.A., Rahman, M.M., Al Aman, D.A.A., Setu, N.I., Banoo, R., Rashid, M.A. Theoretically guided analytical method development and validation for the estimation of rifampicin in a mixture of isoniazid and pyrazinamide by UV spectrophotometer. Frontiers in Chemistry.  5 (Article 27): 1–10.DOI: 10.3389/fchem.2017.00027
21.    Tilinca, M., Hancu, G., Mircia, E., Iriminescu, D., Rusu, A., Vlad, R.A., Barabás, E. Simultaneous determination of isoniazid and rifampicin by UV spectrophotometry. Farmacia. 65(2): 219–224.
22.    Marques, M.S., Morisso, F.D.P., Poletto, F., Guerreiro, I.C.K. Development of derivative spectrophotometric method for simultaneous determination of pyrazinamide and rifampicin in combined formulation. Brazilian Journal of Pharmaceutical Sciences.  57(Article e111454): 1–9.DOI: 10.1590/s2175-97902021e111454
23.    Zilhadia, Z., Supandi, S., Ilahi, A.D.A simple simultaneous UV spectrophotometric method to determine isoniazid and rifampicin contents in combined tablet. International Journal of Research in Pharmaceutical Sciences.  11(1): 123–128. DOI: 10.26452/ijrps. v11i1.2339
24.    Khamar, J.C., Patel, S.A.Q-absorbance ratio spectrophotometric method for the simultaneous estimation of rifampicin and piperine in combined capsule dosage. Journal of Applied Pharmaceutical Science. 4(5): 100–104. DOI: 10.7324/JAPS.2014.40518.
25.    Begum, A.S.K., Raju, B.D., Rao, N.R. Simultaneous estimation of rifampicin and isoniazid in combined dosage form by a simple UV spectrophotometric method. Der Pharma Chemica. 2(2): 1–6.
26.    Patil, J.S., Suresh, S., Sureshbabu, A.R., Rajesh, M.S. Development and validation of liquid chromatography–mass spectrometry method for the estimation of rifampicin in plasma. International Journal of Pharmaceutical Sciences Review and Research. 2(1): 45–50.
27.    Shewiyo, D.H., Kaale, E., Risha, P.G., Dejaegher, B., Smeyers-Verbeke, J., Vander Heyden, Y. Optimization of a reversed-phase high-performance thin-layer chromatography method for these paration of isoniazid, ethambutol, rifampicin and pyrazinamide in fixed-dose combination tablets. Journal of Pharmaceutical and Biomedical Analysis. 70: 373–379. DOI: 10.1016/j.jpba.2012.07.002
28.     Jindal, K.C., Chaudhary, R.S., Gangwal, S.S., Singla, A.K., Khanna, S. High-performance thin-layer chromatographic method for monitoring degradation products of rifampicin in drug–excipient interaction studies. Journal of Planar Chromatography. 18(2): 120–124. 
29.    Shewiyo, D.H., Kaale, E., Risha, P.G., Dejaegher, B., Smeyers-Verbeke, J., Vander Heyden, Y. Optimization of a reversed-phase high-performance thin-layer chromatography method for the separation of isoniazid, ethambutol, rifampicin and pyrazinamide in fixed-dose combination tablets. Journal of Pharmaceutical and Biomedical Analysis.  70: 373–379. DOI: 10.1016/j.jpba.2012.07.002.
30.    Vedaste, K., Egide, K., Pierre Claver, K., Kaale, E. Development and validation of high-performance thin-layer chromatographic method for simultaneous determination of rifampicin, isoniazid and pyrazinamide in fixed-dose combination tablet. Journal of Planar Chromatography – Modern TLC.  28(3): 210–216.DOI: 10.1556/1006.2015.28.3.6
31.    Ali, J., Ali, N., Sultana, Y., Baboota, S., Faiyaz, S. Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs. Journal of Pharmaceutical and Biomedical Analysis.  43(3); 1146–1152.DOI: 10.1016/j.jpba.2006.10.013.



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