Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 5 Issue 11

Method Development, Validation and Stability Indicating Studies of Rifabutin Using HPLC-DAD

Seema B Kharwade1*, Narendra G Patre1, Sunil S Talde2, Asmita S Tupe3, Ajay D Kshirsagar1, Sudam G Mule1

1DK Patil Institute Of Pharmacy, MH, India
2Vivekvardhini Sevabhavi Sanstha's College Of Pharmacy, MH, India
3Prerna Institute Of Pharmacy, MH, India

*Corresponding Author: Seema B. Kharwade DK, Patil Institute Of Pharmacy, MH, India.

Received: August 20, 2021; Published: October 04, 2021;

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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

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References

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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.




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