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Research ArticleRESEARCH

Simple HPLC Determination of Benzalkonium Chloride in Ophthalmic Formulations Containing Antazoline and Tetrahydrozoline

Pornchai Rojsitthisak, Wisut Wichitnithad, Ongart Pipitharome, Kingkan Sanphanya and Peeracha Thanawattanawanich
PDA Journal of Pharmaceutical Science and Technology September 2005, 59 (5) 332-337;
Pornchai Rojsitthisak
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  • For correspondence: pornchai.r@chula.ac.th
Wisut Wichitnithad
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Ongart Pipitharome
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Kingkan Sanphanya
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Peeracha Thanawattanawanich
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Abstract

A simple and rapid analytical procedure for routine quantification of n-C12H25 and n-C14H29 benzalkonium chloride (C-12 and C-14 BKC) homologs in ophthalmic formulations containing antazoline HCl and tetrahydrozoline HCl by high-performance liquid chromatography was developed and validated. The ophthalmic solution samples can be directly analyzed by reversed-phase on HiQ-Sil C18 column (4.6 mm × 150 mm, i.d., 5-μm particle size) with acetonitrile–sodium acetate buffer (pH 5.0; 0.2 M) (70:30, v/v) as mobile phase. UV Detection was carried out at 262 nm. The method was linear over the selected concentration and ranged from 0.03 to 0.10 mg/ml (r2 = 0.9999) and from 0.01 to 0.05 mg/ml (r2 = 0.9979) for C-12 and C-14 BKC homologs, respectively. The mean percent recoveries were 100.2 and 102.6 and the percent CV values were 1.3 and 3.5 for C-12 and C-14 BKC homologs, respectively. The results demonstrated the good linearity, accuracy, and precision. The method was applied to determine two commercial ophthalmic formulations, and the percent label amounts of total BKC contents were found to be 99.7 and 103.2.

  • Benzalkonium chloride
  • Reversed-phase HPLC
  • Determination
  • Ophthalmic formulation

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PDA Journal of Pharmaceutical Science and Technology
Vol. 59, Issue 5
September/October 2005
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Simple HPLC Determination of Benzalkonium Chloride in Ophthalmic Formulations Containing Antazoline and Tetrahydrozoline
Pornchai Rojsitthisak, Wisut Wichitnithad, Ongart Pipitharome, Kingkan Sanphanya, Peeracha Thanawattanawanich
PDA Journal of Pharmaceutical Science and Technology Sep 2005, 59 (5) 332-337;

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Simple HPLC Determination of Benzalkonium Chloride in Ophthalmic Formulations Containing Antazoline and Tetrahydrozoline
Pornchai Rojsitthisak, Wisut Wichitnithad, Ongart Pipitharome, Kingkan Sanphanya, Peeracha Thanawattanawanich
PDA Journal of Pharmaceutical Science and Technology Sep 2005, 59 (5) 332-337;
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