Abstract

Introduction: Pharmaceutical analysis involves separating, identifying and determining relative amounts of the compounds in give formulation. It comprises of those procedures which are necessary to determine the identity, strength, quality and purity of drugs and chemicals. These are classified into non-instrumental and instrumental methods like spectroscopy, chromatography, electrochemical etc.

Aim and Objectives: To develop HPLC-DAD method for the Rifabutin in bulk and capsule dosage form, to validate the developed methods and stability indicating studies as per ICH guidelines.

Method: A Shimadzu SCL-10AVP; Quaternary Pump using C-18 column Zodiac-100 with dimensions of 150 x 4.6 mm and silica particle size of 5 μm. Analyte Concentration of 250 - 15.62 ppm was used. Isocratic elution employed with A; 0.5% Trifluoroacetic Acid, B; Acetonitrile (30:70 v/v) were used. Flow rate was 1.2 ml/min and effluents were monitored at 275 and 310 nm wavelength at 28˚C. HPLC method was extensively validated for precision, robustness and stability indicating studies.

Result: Wavelength of maximum absorbance (λ max) of Rifabutin was 275nm and 310nm and was identical for both marketed preparation and API. Correlation coefficient was found to be 0.999. Interday and intraday precision was 1.93 and 0.89 respectively. The stability indicating studies or force degradation studies were also performed for Rifabutin drug. As concluded, drug was seen stable in thermal, oxidation and acid induced hydrolysis.

Conclusion: It can be concluded that the developed methods are accurate, precise and selective and can be employed successfully for the estimation of Rifabutin in bulk and capsule dosage form.

Keywords: Rifabutin; HPLC-DAD and λ Max

References

1. Neesha Rockwood., et al. “Global access of rifabutin for the treatment of tuberculosis - why should we prioritize this?” Journal of the International AIDS Society 7 (2019): e25333.
2. Carlo Grassi and Vittoria Peona. “Use of Rifabutin in the Treatment of Pulmonary Tuberculosis”. Clinical Infectious Diseases 22 (1996): S50-54.
3. Della Bruna C., et al. “LM 427, a new spiropiperidylrifamycin: in vitro and in vivo studies”. Journal of Antibiotics (Tokyo) 36 (1983): 1502-1506.
4. Grassi C and Peona V. “Use of rifabutin in the treatment of pulmonary tuberculosis”. Clinical Infectious Diseases 22 (1996): S50-S54.
5. Narita M., et al. “Use of rifabutin with protease inhibitors for human immunodeficiency virus-infected patients with tuberculosis”. Clinical Infectious Diseases5 (2000): 779-783.
6. Heifets LB., et al. “Determination of MICs of conventional and experimental drugs in liquid medium by the radiometric method against Mycobacterium avium complex”. Drugs Under Experimental and Clinical Research 13 (1987): 529-538.
7. Woodley CL and Kilburn 10. “In vitro susceptibility of Mycobacterium avium complex and Mycobacterium tuberculosis strains to a spiro-piperidyl rifamycin”. American Review of Respiratory Disease Returns 126 (1982): 586-587.
8. Blaschke TF and Skinner MH. “The clinical pharmacokinetics of rifabutin”. Clinical Infectious Diseases 22 (1996): S15-21; discussion S‐2.
9. Terrence F., et al. “The Clinical Pharmacokinetics of Rifabutin”. Clinical Infectious Diseases 22 (1996): S15-S22.
10. DA Skoog., et al. “Analytical Chemistry”. An Introduction, Saunders College Publications, 1-3.
11. DA Skoog., et al. “Principle of Instrumental Analysis”. 5th ed., Eastern Press, Banglore (2004): 1-2, 678-688, 695-696.
12. GR Chatwal and SK Anand. “Instrumental Methods of Chemical Analysis”. 5th ed., Himalaya Publishing House, Delhi (2004): 1.6-1.7, 2.156-2.158.
13. Frank Settle. “Handbook of Instrumental techniques for Analytical Chemistry”. NJ: Prentice Hall PTR: (1997): 17, 19, 56, 57.
14. Macherey-nagel. Macherey-nagel; Introduction into HPLC (2005).
15. RJ Hamilton and PA Sewell. “Introduction to HPLC”. 2nd ed., Chapman and Hallondon (1982): 189.
16. Sethi PD. “HPTLC, Quantitative Analysis of Pharmaceutical Formulations”. 1st ed, CBS Publishers and Distributors New Delhi (1997): 23.
17. RM Patel., et al. “Stability indicating HPLC method development-A review”. International Research Journal of Pharmacy 5 (2011): 79-87.
18. Yogesh D Patil., et al. “RP-HPLC method for determination of Rifabutine in bulk dosage form”. International Journal of Drug Development and Research2 (2012).
19. Jaiprakas N Sangshetty., et al. “Stability indicating LC method for determination of Rifabutine in bulk drug and pharmaceutical dosage form”. African Journal of Pharmacy and Pharmacology3 (2011): 298-305.
20. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
21. Fifield FW and Kealey D. “Principles and Practice of Analytical Chemistry”. 5th ed. USA: Blackwell publishing 2 (2004): 5-7.

Citation

Citation: Seema B Kharwade., et al. “Method Development, Validation and Stability Indicating Studies of Rifabutin Using HPLC-DAD". Acta Scientific Pharmaceutical Sciences 5.11 (2020): 03-08.

Copyright

Copyright: © 2020 Seema B Kharwade., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.