Determination of benzalkonium chloride in viscous ophthalmic drops of azithromycin by high-performance liquid chromatography

Shen, Yan; Xu, Shengjie; Wang, Shi-chun; Tu, Jiasheng

doi:10.1631/jzus.b0920229

Cited by 12 publications

(6 citation statements)

References 13 publications

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“…An US patent on topical treatment of ocular infections relates to a sustained release ophthalmic composition comprised of an aqueous suspension of the azalide antibiotic and a polymer suspending agent[ 4 ]. However ocular pharmacokinetic results indicated that only a viscous solution of azithromycin can maintain a precorneal concentration above the MIC 90 over 24 h[ 5 ]. Azasite ® , the viscous azithromycin ophthalmic solution, is based on Durasite ® drug delivery technology evolved from cross linked polyacrylic acid[ 6 ].…”

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confidence: 99%

Ion-activated in situ gelling ophthalmic delivery systems of azithromycin

Vijaya¹,

Goud²

2011

Indian J Pharm Sci

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Gelation of pectin caused by divalent cations especially calcium ions has been applied to develop an ophthalmic formulation of azithromycin in the present study. Rapid elimination of drug on instillation into cul de sac would be minimal with in situ gelling ophthalmic solution leading to increased precorneal contact time and prolonged drug delivery. In the formulation development studies pectin was used in different concentrations (1-5% w/v) and different proportions of the hydrocolloids hydroxypropyl methylcellulose and sodium carboxymethyl cellulose of different grades of viscosity were used. The primary criteria for formulation optimization were gelling capacity and rheological behaviour. In addition, formulations were evaluated for pH, and antimicrobial efficacy and drug release. The clarity, pH, gelation in simulated tear fluid and rheological properties of the optimized formulations were satisfactory. The formulations inhibited the growth of Staphylococcus aureus effectively in cup–plate method and were proved to be safe and non irritant on rabbit eyes. The results indicate that pectin based in situ gels can be successfully used to prolong the duration of action of azithromycin.

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confidence: 99%

Ion-activated in situ gelling ophthalmic delivery systems of azithromycin

Vijaya¹,

Goud²

2011

Indian J Pharm Sci

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“…The ''band-aid'' bandage samples in China) were obtained from a local drug store. Benzalkonium chloride sample solution was prepared by dissolving eight pieces of 'band-aid'' bandage samples in 100 mL water, 2.00 mL of these sample solutions containing about 40 lg mL -1 benzalkonium chloride were transferred into colorimetric tubes and determined by the proposed methods and by high performance liquid chromatography (HPLC) [12]. Moreover, to check the validity of the proposed methods, the standard addition method was applied by adding benzalkonium chloride to the previously analyzed solutions.…”

Section: Applicationsmentioning

confidence: 99%

“…Some analytical procedures have been reported for the assay of benzalkonium chloride, such as the potassium iodate titration method [1], the spectrophotometric method [2][3][4][5], the flow injection analytical method [6], the capillary zone electrophoresis method [7,8], the gas chromatographic method [9,10], and the high performance liquid chromatographic method [11][12][13][14]. In contrast, spectrophotometric methods utilise inexpensive instruments and simple operational procedures and allow rapid determination.…”

Section: Introductionmentioning

confidence: 99%

Two Spectrophotometric Methods for the Assay of Benzalkonium Chloride in Bandage Samples

Wei-xing

Sha

et al. 2013

J Surfact & Detergents

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Two rapid, direct, extraction-free spectrophotometric procedures were developed for the determination of benzalkonium chloride. The procedures were based on the formation of mixed dye-surfactant aggregates between eosine Y and benzalkonium chloride (Method A), or between eosine B and benzalkonium chloride (Method B) in Clark-Lubs medium by measuring the increase in absorbance at 556 and 550 nm, respectively. Beer's law was obeyed in the concentration range of 0.5-12 and 0.5-12 lg mL -1 for benzalkonium chloride with good precision and accuracy, whose limits of detection were 0.1 lg mL -1 at 556 nm for Method A and 0.2 lg mL -1 at 550 nm for Method B, respectively. The proposed procedures were successfully applied to the assay of benzalkonium chloride in bandages. The analytical results of the real samples were in good agreement with those by HPLC.

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“…A number of analytical methods have been reported for the estimation of BKC in various products including ophthalmic preparations [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]. However, there was no method available for estimation of BKC in azelastine hydrochloride ophthalmic formulations.…”

Section: Introductionmentioning

confidence: 99%

A Study on Forced Degradation and Validation of Stability Indicating Rp-HPLC Method for Determination of Benzalkonium Chloride in Azelastine Hydrochoride Pharmaceutical Ophthalmic Formulation

Gupta

Chaturvedi

2017

Asian J Pharm Clin Res

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Objective: This study was designed to conduct forced degradation and validation studies for determination the benzalkonium chloride (BKC) as major homologues form in azelastine hydrochloride pharmaceutical ophthalmic formulation by a novel stability indicating reverse phase high-performance liquid chromatographic method (RP-HPLC).Methods: Forced degradation study and validation were carried out with a analytical approach of reverse phase chromatographic analysis with C18, cosmosil (250mm x 4.6mm i.d. x 5µm) column using mobile phase consisting acetonitrile -buffer of pH 5.0 with 5N NaOH (45:55 %v/v) at a flow rate of 1.5 ml per minute. Column temperature was maintained at 25°C and detection wavelength was 210nm.By using these chromatographic conditions of method, two major homologues of benzalkonium chloride were separated without any interference of drug components and exciepients.Results: Forced degradation studies were carried out as per ICH guidelines and established a stability indicating property of a method .The method was found linear in concentration range 40µg/ml to 60µg/ml (50µg/ml±20%), correlation coefficient was found 0.999. The recovery was found to be 99.2%, 100.7% and 101.4% at ±30% of target concentration. The %RSD for method precision and intermediate precision were found 0.28% and 0.30 % respectively. The method was found specific, selective, precise, accurate, linear, robust and stability indicating for quantification benzalkonium chloride in azelastine pharmaceutical ophthalmic formulation. Conclusion:The method has been found successful for determination of BKC pharmaceutical formulation and validated for all the parameters of validation and found within the acceptance criteria as per ICH guideline Q2R1.

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Determination of benzalkonium chloride in viscous ophthalmic drops of azithromycin by high-performance liquid chromatography

Cited by 12 publications

References 13 publications

Ion-activated in situ gelling ophthalmic delivery systems of azithromycin

Ion-activated in situ gelling ophthalmic delivery systems of azithromycin

Two Spectrophotometric Methods for the Assay of Benzalkonium Chloride in Bandage Samples

A Study on Forced Degradation and Validation of Stability Indicating Rp-HPLC Method for Determination of Benzalkonium Chloride in Azelastine Hydrochoride Pharmaceutical Ophthalmic Formulation

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