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Asian Journal of Pharmaceutical Analysis
Year : 2020, Volume : 10, Issue : 1
First page : ( 32) Last page : ( 36)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2020.00007.1

Development and Validation of High-Performance Thin Layer Chromatography Method for Estimation of Rifabutin in Bulk and Formulation

Bhusari Sachin*, Ansari Irfan, Wakte Pravin

University Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, Maharashtra, India

*Corresponding Author E-mail: chemtech.cdmpk@gmail.com

Online published on 3 June, 2020.

Abstract

A new, simple, rapid, accurate and precise high-performance thin layer chromatography (HPTLC) method has been developed and validated according to the guidelines of the International Conference on Harmonization (ICH Q2(R1) for the estimation of rifabutin in bulk and formulation. Optimized HPTLC mobile phase composition for rifabutin estimation was Chloroform: Methanol: n-Hexane (5: 1: 4 v/v/v). Spectro densitometric analysis of Rifabutin was carried out at 260nm and asymmetrical, well-resolved, well-defined peak was obtained at mean retardation factor (Rf) 0.84. The calibration plots were found to be linear in the range of 50 to 300 ng/spot and showed a good linear relationship with the coefficient of regression, R2=0.979 with respect to the peak area. The limit of detection and quantification of developed HPTLC method were 0.28 and 0.84ng/spot, respectively. The recovery study was carried out by standard addition method and the percentage recovery was found to be in between 99.68 to 100.35. Proposed HPTLC method can be applied for the quantitative determination of rifabutin in bulk drug and formulation.

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Keywords

Rifabutin, High Performance Thin Layer Chromatography, Method validation.

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