Determination of benzalkonium chloride preservative in pharmaceutical formulation of eye and ear drops using new potentiometric sensors

Gaber, Mohamed; Shawish, Hazem M. Abu; Khedr, Abdalla M.; Abed-Almonem, Khalid I.

doi:10.1016/j.msec.2012.06.018

Cited by 34 publications

(16 citation statements)

References 33 publications

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“…Therefore, the equilibrium is hampered and shifted to the right by consumption of some drug anions on formation of the insoluble drug in the paste with the effect of slow decrease of the ion-exchanger and a decrease in the concentration of the active species of the sensor, a similar explanation to a few recently reported sensors. 60…”

Section: Ph Dependencementioning

confidence: 99%

Determination of Atomoxetine Hydrochloride in Biological Fluids Using Potentiometric Carbon Paste Electrode Modified by TiO2 Nanoparticles

Shawish

Saadeh

Tamous

et al. 2018

ACSi

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Endeavors to improve the limit of detection for atomoxetine-selective electrode were documented. Simple potentiometric carbon paste electrodes (CPEs) based on atomoxetine-derivatized with tetraphenylborate (ATM-TPB) or phosphotungstic acid (ATM-PTA) as ion-pairs decorated with TiO 2 nanoparticles and sodium tetraphenylborate (Na-TPB) as additives were most useful. Parameters affecting the performance of the electrodes were investigated, such as paste composition, type of plasticizers, kind of electroactive materials and interfering species. The electrodes were notable for bringing down the detection limit to 8.0 × 10-7 M and 9.2 × 10-7 M, wide linear ranges 1.1 × 10-6-1.0 × 10-2 M and 1.75 × 10-6-1.00 × 10-2 M, slope 58.7 ± 0.5 mV/decade and 67.2 ± 0.8 mV/decade, respectively. Importantly, the potential reading became more stable and rapidly attained in the presence of additives. The selectivity for the drug over other species such as inorganic and organic cations, as well as different excipients that are likely incorporated in pharmaceutical preparations was high making their effect negligible on the response of the electrodes. The sensors, as indicator electrodes, were successfully applied for determination of the drug in pharmaceutical preparation, urine and serum with good accuracy, excellent recovery and efficiency.

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Section: Ph Dependencementioning

confidence: 99%

Determination of Atomoxetine Hydrochloride in Biological Fluids Using Potentiometric Carbon Paste Electrode Modified by TiO2 Nanoparticles

Shawish

Saadeh

Tamous

et al. 2018

ACSi

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“…Ion-exchanger sensing materials containing HY were made according to a previously reported method, [17] from HY-silicotungstate, (HY-ST), phosphotungstate (HY-PT) and phosphomolybdate (HY-PM). Preparation of (HY-ST) was carried out by mixing the two solutions in the ratio of 4:1, i.e., 50 mL of 0.01M HY was mixed with 12.5 mL of 0.01M solution of silicotungstate (ST), phosphotungstate (PT) and phosphomolybdate (PM) were prepared by adding 50 mL of 0.01M solution of HY to the appropriate volume of 10 -2 M solution to 16.7 mL of 0.01 M of one of (HY-PT) or (HY-PM).…”

Section: Preparation Of Ion-exchangersmentioning

confidence: 99%

Nanomolar Detection of Alkyl Dimethyl Hydroxyethyl Ammonium Surfactant by a Lipophile-doped Solid Contact Electrode

Shawish¹,

Gaber²,

Khedr³

et al. 2014

J Environ Anal Chem

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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 preservative in pharmaceutical formulation of eye and ear drops using new potentiometric sensors

Cited by 34 publications

References 33 publications

Determination of Atomoxetine Hydrochloride in Biological Fluids Using Potentiometric Carbon Paste Electrode Modified by TiO2 Nanoparticles

Determination of Atomoxetine Hydrochloride in Biological Fluids Using Potentiometric Carbon Paste Electrode Modified by TiO2 Nanoparticles

Nanomolar Detection of Alkyl Dimethyl Hydroxyethyl Ammonium Surfactant by a Lipophile-doped Solid Contact Electrode

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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