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Sci. Pharm. 2013, 81(3), 733-748; doi:10.3797/scipharm.1303-05

Validation of a Stability-Indicating Hydrophilic Interaction Liquid Chromatographic Method for the Quantitative Determination of Vitamin K3 (Menadione Sodium Bisulfite) in Injectable Solution Formulation

1
Pharmacare Pharmaceutical Company, P.O. Box 677, Ramallah, Palestine
2
Faculty of Pharmacy, Al-Quds University, P.O. Box 20002, Abu-Dies, Palestine
*
Author to whom correspondence should be addressed.
Received: 5 March 2013 / Accepted: 9 May 2013 / Published: 9 May 2013
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Abstract

A simple, specific, accurate, and stability-indicating method was developed and validated for the quantitative determination of menadione sodium bisulfite in the injectable solution formulation. The method is based on zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC) coupled with a photodiode array detector. The desired separation was achieved on the ZIC-HILIC column (250 mm × 4.6 mm, 5 μm) at 25°C temperature. The optimized mobile phase consisted of an isocratic solvent mixture of 200mM ammonium acetate (NH4AC) solution and acetonitrile (ACN) (20:80; v/v) pH-adjusted to 5.7 by glacial acetic acid. The mobile phase was fixed at 0.5 ml/min and the analytes were monitored at 261 nm using a photodiode array detector. The effects of the chromatographic conditions on the peak retention, peak USP tailing factor, and column efficiency were systematically optimized. Forced degradation experi-ments were carried out by exposing menadione sodium bisulfite standard and the injectable solution formulation to thermal, photolytic, oxidative, and acid-base hydrolytic stress conditions. The degradation products were well-resolved from the main peak and the excipients, thus proving that the method is a reliable, stability-indicating tool. The method was validated as per ICH and USP guidelines (USP34/NF29) and found to be adequate for the routine quantitative estimation of menadione sodium bisulfite in commercially available menadione sodium bisulfite injectable solution dosage forms.
Keywords: Menadione sodium bisulfite; Menadione sodium bisulfite injectable solution; Validation; Stability indicating method; Liquid chromatography; Vitamin K Menadione sodium bisulfite; Menadione sodium bisulfite injectable solution; Validation; Stability indicating method; Liquid chromatography; Vitamin K
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

GHANEM, M.M.; ABU-LAFI, S.A.; HALLAK, H.O. Validation of a Stability-Indicating Hydrophilic Interaction Liquid Chromatographic Method for the Quantitative Determination of Vitamin K3 (Menadione Sodium Bisulfite) in Injectable Solution Formulation. Sci. Pharm. 2013, 81, 733-748.

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