title: Validation of an RPHPTLC-Densitometric Method Using Silica Gel 60 RP18WF254 for Simultaneous Determination of Nicotinamide in Selected Pharmaceutical Formulations.
abstract: This research study describes the applicability of silica gel 60 RPW18F254 plates for the development and validation of new, simple, economic, accurate, and precise RPHPTLC-densitometric method suitable for the quantification of nicotinamide (as Vitamin PP) in three marketed preparations. The mobile phase used was methanol-water in volume composition 3 : 7. Detection wavelength was 200 nm. The proposed method was validated according to ICH guidelines and also based on Ferenczi-Fodor and Konieczka reports. Results were found to be linear over a range of 1.00 to 2.00 μg/spot. Limit of detection (LOD) and limit of quantification (LOQ) were 0.15 μg/spot and 0.45 μg/spot, respectively. The percent content of nicotinamide in the investigated preparations was found to be 99.2% (Product 1), 99.3% (Product 2), and 99.4% (Product 3). Developed method is accurate and precise (CV < 3%) and may be successfully applied for the quality control of pharmaceutical formulations containing nicotinamide in the presence of its derivatives, such as N,N-diethylnicotinamide, N-methylnicotinamide, and nicotinic acid.
authors.affiliation: Institute of Analytical Chemistry, Department of General and Analytical Chemistry, School of Pharmacy and the Division of Laboratory Medicine, Medical University of Silesia in Katowice, 4 Jagiellońska Street, 41-200 Sosnowiec, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Dołowy
authors.affiliation: Institute of Analytical Chemistry, Department of General and Analytical Chemistry, School of Pharmacy and the Division of Laboratory Medicine, Medical University of Silesia in Katowice, 4 Jagiellońska Street, 41-200 Sosnowiec, Poland.
authors.forename: Alina
authors.initials: A
authors.lastname: Pyka
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