9.
Validation of a High performance thin layer chromatography
method for the estimation of Rifaximin in Pharmaceutical Formulation
Mukesh C. Sharma1 and Smita Sharma2
1School
of Pharmacy, Devi Ahilya University, Takshila Campus, Khandwa Road,
Indore – 452 017, India
2 Department of Chemistry Chodhary Dilip Singh Kanya
Mahavidyalya, Bhind (M.P) 477001, India
E-mail:
mukeshcsharma@yahoo.com (Mukesh C.
Sharma),
drsmita.sharma@rediffmail.com (Dr
Smita Sharma)
Abstract:
The
present work describes a simple, precise and accurate HPTLC
method for its estimation as bulk and in tablet dosage form. The
chromatographic separation was carried out on precoated silica
gel 60 F254 aluminium plates using mixture of
methanol: hexane : ammonia (8:3:1v/v/v) as mobile phase and
densitometric evaluation of spots were carried out at 265nm
using Camag TLC scanner-3 with WINCAT 1.3.4 version software.
The experimental parameters like band size of spot applied,
chamber saturation time, solvent front migration, slit width etc
were critically studied and optimum conditions were evolved. The
drug was satisfactorily resolved with Rf value 0.73 ± 0.06.The
linear regression analysis data for the calibration plots showed
good linear relationship with concentration range of 200–1000 ng.spot-1.
The mean value of correlation coefficient, slope and intercept
were 0.9986. The method was validated for precision, robustness
and recovery. The limits of detection and quantitation were 29
and 65 ng.spot-1, respectively. Statistical analysis
proves that the method is repeatable and selective for the
estimation of the drug. The drugs were separated on silica gel
60 F254 plates using suitable combination of solvents
as mobile phase. The validation parameters, tested in accordance
with the requirements of ICH guidelines, prove the suitability
of methods.
Keywords: Rifaximin; HPTLC, ICH guidelines.
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