Validated HPLC Method to Simultaneously Determine Amprolium Hydrochloride, Sulfaquinoxaline Sodium and Vitamin K3 in A.S.K Powder on ZIC-HILIC Column

Ghanem, Mashhour; Abu‐Lafi, Saleh; Hallak, Hussein

doi:10.4172/2153-2435.1000168

Cited by 3 publications

(2 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Some of these methods utilized reversed-phase ion-pairing with UV detection [2], dual-electrode amperometry [3], fluorescence [4, 5], and electrochemical detection [6]. Recently, we have successfully developed a novel validated HPLC method for the simultaneous determination of MSB combined with amprolium hydrochloride and sulfaquinoxaline sodium in the powder formulation [7]. The official BP and USP methods for MSB analysis rely on the titration of menadione as an active ingredient [8, 9].…”

Section: Introductionmentioning

confidence: 99%

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

Ghanem¹,

Abu‐Lafi²,

Hallak³

2013

Sci. Pharm.

View full text Add to dashboard Cite

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 experiments 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.

show abstract

Section: Introductionmentioning

confidence: 99%

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

Ghanem¹,

Abu‐Lafi²,

Hallak³

2013

Sci. Pharm.

View full text Add to dashboard Cite

show abstract

“…Literatürde AmprolyumHCl, sulfakuinoksalin sodyum ve Vitamin K3 sodyum bisülfit (menadion sodyum bisülfit olarak) içeren tozların (A.S.K tozları) tayini için HPLC metodu ve ZIC-HILIC kolonu kullanılarak Amprolyum HCl ve Vitamin K'nın bir arada analizinin yapıldığı görülmektedir [15]. Bir başka çalışmada ise HPLC metodu kullanılarak gıda maddelerinde koruyucu maddelerin (metilparaben ve propilparaben) tayinleri bir arada yapılmıştır [16].…”

unclassified

Quantitative HPLC Analysis of Vitamin K3-Amprolium HCl-Methylparaben-Propylparaben in Oral Solutions

Osanmaz

Bayraktar

Ergün

2019

Düzce Üniversitesi Bilim Ve Teknoloji Dergisi

View full text Add to dashboard Cite

Bu çalışmada antiprotozoal etkili amprolyum HCl, kanın pıhtılaşmasını önleme açısından etkili vitamin K3, antimikrobiyal koruyucu etkili metilparaben ve propilparabeni bir arada içeren oral çözeltisinin zaman açısından avantajı nedeniyle eşzamanlı bir HPLC yöntemi ile miktar tayini ve validasyon çalışmaları yapılmıştır. Analizlerde 25°C'de İnertsil C8-3 4,6 x 250 mm, 5 µm kolon, 254nm'de dalga boyunda heptan-1-sülfonik asit sodyum tuzu, glasiyel asetik asit, trietilamin tampon çözeltisi ve asetonitril ve metanol kullanılmıştır. Seçicilik, sistem uygunluk, doğrusallık ve doğruluk parametreleri çalışılmış ve kabul edilebilir sonuçlar elde edilmiştir.

show abstract

Comprehensive comparative study of eco-friendly Univariate and multivariate methodological approaches on processing multi-component formulation quality

Fayez

Michael

Monir

et al. 2020

Spectrochimica Acta Part A: Molecular and Biomolecular Spectros

View full text Add to dashboard Cite

Validated HPLC Method to Simultaneously Determine Amprolium Hydrochloride, Sulfaquinoxaline Sodium and Vitamin K3 in A.S.K Powder on ZIC-HILIC Column

Cited by 3 publications

References 7 publications

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

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

Quantitative HPLC Analysis of Vitamin K3-Amprolium HCl-Methylparaben-Propylparaben in Oral Solutions

Comprehensive comparative study of eco-friendly Univariate and multivariate methodological approaches on processing multi-component formulation quality

Contact Info

Product

Resources

About