Development And Validation Of Rp-Hplc Method For Estimation Of Rifapentine.

Authors

  • Sonali D.Pawar
  • Vaishali D. Rakibe
  • Kavita T.Daware
  • Snehal D.Pawar

Keywords:

dosage forms, RP-HPLC, Delamanid, and method validation

Abstract


Reverse-phase high-performance liquid chromatography was developed and validated as a simple, accurate, precise and sensitive method for estimation of Delamanid in bulk and pharmaceutical dosage form. Chromatography was carried out on C18 column using a mixture of HPLC grade Methanol; 0.1% ortho phosphoric acid (81/19) as the mobile phase at a flow rate of 1.1 mL/min.  The detection was carried out at 222 nm. It was determined that the retention time was 4.278 ± 0.12 min. The method produces linear response in the concentration range of 10 to 50 µg/mL of Rifapentine. The method precision for the determination of assay was below 2%RSD. Accuracy was found in the limit. The method is useful in the quality control of bulk and pharmaceutical dosage form.

Downloads

Download data is not yet available.

References

1. Ansari Tahir, Kalkotwar R. S, Patil Sachin, Momin Haseeb and Jameel Asghar, 2014 Development and Validation of RP-HPLC Method for the Estimation of Rifapentine in Bulk and Pharmaceutical Formulation, pp.76-84.

2. Sterling T. R, Villarino M. E, Borisov A. S, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, et al; TB Trials Consortium prevent TB Study Team. Three months of Rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med 2011; Volume 365. p; 2155-66. (PubMed).

3. Dorman SE, Goldberg S, Stout JE, Muzanyi G, Johnson JL, Weiner M, Bozeman L, et al; Tuberculosis Trials Consortium. Substitution of Rifapentine for Rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the tuberculosis trials consortium. J Infect Dis 2012; 206: p; 1030-40. (PubMed).

4. American Thoracic Society, Centers for Disease Control and Prevention, Infectious Diseases Society of America.Treatment of Tuberculosis. Am J RespirCrit Care Med. 2003; 167: p; 603-662.

5. E. Miyazaki, R.E. Chaisson, W.R. Bishai, Analysis of Rifapentine for Preventive Therapy in the Cornell Mouse Model of Latent Tuberculosis Antimicrobial Agents and Chemotherapy. Sept-1999, Vol-43, 2126-213.

6. Hye S. Lee, Ho C. Shin, Sang S. Han, Jung K. Roh, High-performance liquid chromatographic determination of rifapentine in serum using column switching, Journal of Chromatography B: Biomedical Sciences and Applications, Issue 1, 1992, Vol. 574, 175– 178,

7. Riva E, Merati R, Cavenaghi L,Highperformance liquid chromatographic determination of rifapentine and its metabolite in human plasma by direct injection into a shielded hydrophobic phase column, Journal of Chromatography A , Volume 553, 1991, Vol.553, 35–40, 18th International Symposium on Chromatography.

Downloads

Published

2025-12-13

How to Cite

1.
D.Pawar S, D. Rakibe V, T.Daware K, D.Pawar S. Development And Validation Of Rp-Hplc Method For Estimation Of Rifapentine. J Neonatal Surg [Internet]. 2025 Dec. 13 [cited 2026 May 9];14(33S):973-80. Available from: https://jneonatalsurg.com/index.php/jns/article/view/10198

Issue

Vol. 14 No. 33S (2025): Journal of Neonatal Surgery

Section

Original Article

License

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

You are free to:

  • Adapt — remix, transform, and build upon the material for any purpose, even commercially.

Terms:

  • Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
  • No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.