Quantitative Determination of Benzalconium Chloride in the Naltrexone Hydrochloride Nasal Spray

Introduction. Benzalkonium chloride is widely used as a conservation agent in medicines. For quantitative determination, the methods described in the European and American Pharmacopoeias by chromatography using columns with nitrile sorbent are often used. However, in order to unify the methods and simplify the quality control technology in the production process, it is advisable to adapt the existing methods for new goals and objectives.Aim. To develop a method for the quantitative determination of benzalkonium chloride in a nasal spray containing a thermosensitive polymer Poloxamer 407 and validate it.Materials and methods. As an object of research, a naltrexone hydrochloride nasal spray was used. The quantitative determination of naltrexone in the test sample was developed using a Dionex UltiMate 3000 high-performance liquid chromatograph (Thermo Fisher Scientific, USA) equipped with a diode-matrix detector.Results and discussion. The paper explored the possibility of using an earlier developed method for the quantitative determination of naltrexone hydrochloride for the quantitative determination of benzalkonium chloride in the composition of a nasal spray. Based on the results obtained, changes were made to the quantitative determination method, and the sample preparation of the samples under study was adapted.Conclusion. As a result of the studies carried out, the most acceptable conditions for the preparation of the nasal spray for the quantitative determination of the preservative were selected. The developed technique provides for the chromatographic conditions previously used for the determination of naltrexone hydrochloride, which makes it possible to use the equipment as efficiently as possible in the analysis of the finished drug. The method has been validated and its specificity, linearity, correctness and precision have been proven.

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Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography

Drug development & registration ◽

10.33380/2305-2066-2020-9-2-98-104 ◽

2020 ◽

Vol 9 (2) ◽

pp. 98-104 ◽

Cited By ~ 1

Author(s):

Yu. M. Domnina ◽

V. V. Suslov ◽

S. A. Kedik ◽

E. V. Vorfolomeeva ◽

A. V. Meleshko

Keyword(s):

High Performance Liquid Chromatography ◽

Liquid Chromatography ◽

Quantitative Determination ◽

Nasal Spray ◽

High Performance ◽

Test Sample ◽

Water Soluble ◽

High Concentration ◽

Naltrexone Hydrochloride

Introduction. Naltrexone, an antagonist of µ-opioid receptors, is promising for the treatment of various autoimmune and oncological diseases when used in doses of 1.5–5 mg/day. To date, there are no medications that provide such dosages of naltrexone.Aim. Development and validation of a method for the quantitative determination of naltrexone hydrochloride in a nasal spray by high performance liquid chromatography (HPLC).Materials and methods. As an object of research, a naltrexone hydrochloride nasal spray was used. The quantitative determination of naltrexone in the test sample was developed using a Dionex UltiMate 3000 high-performance liquid chromatograph (Thermo Scientific, USA) equipped with a diode-matrix detector.Results and discussion. The possibility of using isocratic and gradient chromatographic modes for the quantitative determination of naltrexone hydrochloride in the nasal spray was studied. Based on these results, a new method of determination using the gradient mode is proposed, which allows minimizing the influence of the polymer component in the test sample on the analysis results.Conclusion. A new technique of high-performance liquid chromatography (HPLC) is proposed that allows identification and quantification of naltrexone hydrochloride in a nasal spray containing a high concentration of water-soluble heat-sensitive poloxamer as a thickener. The developed method was validated according to the parameters: correctness, precision, specificity, linearity.

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Validation of assay method of nifedipine in tablets by liquid chromatography

Medical and Clinical Chemistry ◽

10.11603/mcch.2410-681x.2016.v0.i4.7267 ◽

2017 ◽

Author(s):

L. S. Lohoyda

Keyword(s):

Liquid Chromatography ◽

Quantitative Determination ◽

High Performance ◽

Hplc Method ◽

Assay Method ◽

Liquid Chromatograph ◽

System A ◽

Validation Of Methods ◽

Validation Parameters

The aim of this study was the validation of methods of quantitative determination of nifedipine in tablets by liquid chromatography. The chromatographic analysis was performed on nifedipine liquid chromatograph Agilent 1290 Infinity II LC System. A validation of methods of quantitative determination of nifedipine by high performance liquid chromatography tablets was performed. It was established that the method proves the requirements of the State Pharmacopoeia of Ukraine for the main validation parameters: specificity, accuracy, linearity, robasnist. The results obtained in this study clearly indicate that the developed HPLC method is fast, economical, simple, accurate and suitable for determination of nifedipine in medicines.

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DEVELOPMENT AND VALIDATION OF METHODS FOR QUANTITATIVE DETERMINATION OF ACTIVE PHARMACEUTICAL SUBSTANCES IN NASAL SPRAY

Pharmacy & Pharmacology ◽

10.19163/2307-9266-2021-9-4-266-277 ◽

2021 ◽

Vol 9 (4) ◽

pp. 266-277

Author(s):

M. V. Larskiy ◽

A. E. Pozdnyakova ◽

Z. D. Khadzhieva ◽

D. I. Pozdnyakov

Keyword(s):

Quantitative Determination ◽

Nasal Spray ◽

High Performance ◽

Potassium Dihydrogen Phosphate ◽

Dihydrogen Phosphate ◽

Active Pharmaceutical Ingredients ◽

Potassium Dihydrogen ◽

Pharmaceutical Ingredients ◽

Development And Validation

Intranasal administration of H1-histamine receptor blockers may be a promising approach to the treatment of allergic rhinitis. Earlier, an original composition of a nasal spray containing fexofenadine hydrochloride and ammonium glycyrrhizinate and demonstrating a high level of therapeutic efficacy, was developed.The aim of the study was to develop and validate a method of the quantitative determination of active pharmaceutical ingredients fexofenadine hydrochloride and ammonium glycyrrhizinate in a spray for intranasal administration.Materials and methods. During the development and validation of the method of the fexofenadine hydrochloride and ammonium glycyrrhizinate quantitative determination in a nasal spray, the method of high performance liquid chromatography was used: a Dionex Ultimate 3000 UV chromatograph with a Luna C18 column (2) containing octadecylsilicagel with a 5 μm grain size as a sorbent. The analysis and validation procedures were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, the XIVth edition.Results. The study showed that for the simultaneous quantitative determination of fexofenadine hydrochloride and ammonium glycyrrhizinate, the optimal elution regime is a gradient mode with a mobile phase containing 50 mmol/L potassium dihydrogen phosphate solution with methanol (45:55), which ensured the separation of the components in the 20 minutes interval. The validation procedures showed that the developed methodology correspond to all the criteria of validity in terms of the following indicators: correctness, precision, specificity and linearity in the analytical area.Conclusion. The obtained results indicate the possibility of using the method of high-performance liquid chromatography in a gradient elution mode with a mobile phase of the composition of a 50 mmol/L solution of potassium dihydrogen phosphate with methanol (45:55) for the simultaneous quantitative determination of active pharmaceutical ingredients – fexofenadine hydrochloride and ammonium glycyrrhizinate as parts of a promising nasal spray for the allergic rhinitis treatment.

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Quantitative determination of xylo-oligosaccharides in xylo-oligosaccharide products with high performance anion-exchange chromatography coupled with pulsed amperometric detection

Chinese Journal of Chromatography ◽

10.3724/sp.j.1123.2011.00075 ◽

2011 ◽

Vol 29 (1) ◽

pp. 75-78 ◽

Cited By ~ 2

Author(s):

Li FAN ◽

Yong XU ◽

Zhina LIAN ◽

Qiang YONG ◽

Shiyuan YU

Keyword(s):

Quantitative Determination ◽

Anion Exchange ◽

High Performance ◽

Amperometric Detection ◽

Anion Exchange Chromatography ◽

Exchange Chromatography ◽

Pulsed Amperometric Detection

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The Dtermination of Paracetamol by HPLC Validation of the Method and Application on Serum Samples

Revista de Chimie ◽

10.37358/rc.18.3.6163 ◽

2018 ◽

Vol 69 (3) ◽

pp. 627-631 ◽

Cited By ~ 2

Author(s):

Viorica Ohriac (Popa) ◽

Diana Cimpoesu ◽

Adrian Florin Spac ◽

Paul Nedelea ◽

Voichita Lazureanu ◽

...

Keyword(s):

Mobile Phase ◽

High Performance ◽

Hplc Analysis ◽

Emotional Experience ◽

Optimum Conditions ◽

Serum Samples ◽

Liquid Chromatograph ◽

Mobile Phase Flow Rate ◽

Quantification Limit

Pain is defined as a disagreeable sensory and emotional experience related to a tissue or potential lesion. Paracetamol (Acetaminophen) is the most used non-morphine analgesic. For the determination of paracetamol we developed and validated the high performance liquid chromatography (HPLC) analysis using a Dionex Ultimate 3000 liquid chromatograph equipped with a multidimensional detector. After determining the optimum conditions of analysis (80/20 water / acetonitrile mobile phase, flow rate 1.0 mL / min, detection wavelength 245 nm) we validated the method following the following parameters: linearity of response function, linearity of results, limit (LD = 0.66 mg / mL) and quantification limit (LQ = 2.00 mg / mL), and precision. The method of determining paracetamol by HPLC was applied to 30 samples of serum collected from patients who had pain and were treated with paracetamol.

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