Spectrophotometric method for the determination, validation, spectroscopic and thermal analysis of diphenhydramine in pharmaceutical preparation

Ulu, Sevgi Tatar; Elmalı, Fikriye Tuncel

doi:10.1016/j.saa.2010.05.031

Cited by 20 publications

(10 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Upon interaction with poly(glutamic acid) to form stable complexes the endothermic peak increased to 238°C and the exothermic peak to 245°C [28]. On a separate study, the DPH showed one degradation step at 190-330°C corresponding to the loss of DPH and the weight loss of this step was 92% [35]. In the present study, the peak decomposition temperature was at 254°C with a shoulder at 192°C for crystalline DPH (Fig.…”

Section: Tg-dtg Analysessupporting

confidence: 50%

Removal of diphenhydramine from water by swelling clay minerals

Chang

Jiang

et al. 2011

Journal of Colloid and Interface Science

View full text Add to dashboard Cite

Section: Tg-dtg Analysessupporting

confidence: 50%

Removal of diphenhydramine from water by swelling clay minerals

Chang

Jiang

et al. 2011

Journal of Colloid and Interface Science

View full text Add to dashboard Cite

“…Methods that use reactions between different dyes and diphenhydramine are based on the formation of a complex between anionic dyes and positively charged basic groups in acid medium, which results in a coloured complex with strong absorption in the visible range of electromagnetic spectrum [8][9][10][11]. Although they present appropriate parameters of validation, they also exhibit some limitations in formulations where active ingredients are mixed with diphenhydramine-like basic groups.…”

Section: Discussionmentioning

confidence: 99%

“…Some methods for diphenhydramine analysis propose the extraction of a coloured complex formed between the analyte and some dye, such as eriochrome black T, bromocresol purple, methyl orange, bromocresol green and rose bengal, using organic solvents. These methods provide an improved capacity of detection and drug selectivity, but their extraction requires the use of an organic solvent of the formed complex [8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Analytical Method Development by Solid Phase Extraction and High-Performance Liquid Chromatography for Diphenhydramine Quantification in Syrups

Hurtado

Medina

2017

Int J App Pharm

View full text Add to dashboard Cite

Objective: To develop a method for the determination of diphenhydramine hydrochloride in syrups. Methods:The developed method is based on the active ingredient recovery from the pharmaceutical formulation using a cartridge for selective solid phase extraction. This procedure is simple and fast as compared to the methods that require liquid/liquid extraction. Once the sample is eluted from the cartridge, it is injected directly into a reversed-phase chromatographic system containing a mixture of acetonitrile: 10 mmol ammonium acetate: triethylamine 60:39.5:0.5. Results:The proposed method fulfilled the validation parameters (linearity R 2 Conclusion:The proposed method proved to be reliable when it was applied in the quantification of diphenhydramine hydrochloride of two commercial syrup products.>0.99, precision CV<2% and accuracy 98-102%).

show abstract

“…The samples were previously prepared and transferred to sealed tubes and refrigerated at 4 °C or maintained at different temperatures (25 and 37 °C) for 24 h prior to analysis. Assays were performed three times under the same conditions (ANVISA, 2003;Ulu, Elmali, 2010).…”

Section: Robustnessmentioning

confidence: 99%

Validation of a UV-spectrophotometric analytical method for determination of LPSF/AC04 from inclusion complex and liposomes

Ferraz

Mendonça

Silva

et al. 2015

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

The aim of this study was to develop and validate a UV spectrophotometric method for determination of LPSF/AC04 from inclusion complex and encapsulated into liposomes. The validation parameters were determined according to the International Conference on Harmonisation (ICH) and National Health Surveillance Agency (ANVISA) guidelines. LPSF/AC04 was determined at 250 nm in methanol by a UV spectrophotometric method, exhibiting linearity in the range from 0.3 to 2 µg.mL −1 (Absorbance=0.18068 x [LPSF/AC04 µg.mL -1 ] + 0.00348), (r 2 =0.9995). The limits of detection and quantification were 0.047µg.mL −1 and 0.143µg.mL −1 , respectively. The method was accurate, precise, reproducible and robust since all the samples analyzed had coefficient of variation of less than 5% and no statistically significant difference between theoretical and practical concentrations was detected. Thus, a rapid, simple, low cost and sensitive spectrophotometric method was developed and validated for determining the content of inclusion complex and liposomes containing LPSF/AC04. Uniterms:UV Spectrophotometry/quantitative analysis/method validation. Acridine derivatives/ determination. Inclusion complex. Liposomes.O objetivo deste estudo foi desenvolver e validar um método espectrofotométrico para determinação do LPSF/AC04 em complexo de inclusão e encapsulado em lipossomas. Os parâmetros de validação foram determinados de acordo com o International Conference on Harmonisation (ICH) e Agência Nacional de Vigilância Sanitária (ANVISA). OLPSF/AC04 foi determinado a 250 nm em metanol pelo método espectrofotométrico UV, que apresenta linearidade na faixa de 0,3 a 2 µg/mL (Absorbância = 0,18068 x [LPSF/AC04 µg/mL] + 0,00348), (r 2 = 0,9995). Os limites de detecção e quantificação foi 0,047 µg/mL e 0,143 µg/mL, respectivamente. O método foi exato, preciso, reprodutível e robusto e todas as amostras analisadas apresentaram coeficiente de variação menor que 5% e não houve diferença estatisticamente significante entre a concentração teórica e a prática. Assim, um método espectrofotométrico rápido, simples, sensível e de baixo custo foi desenvolvido e validado para determinar o conteúdo do LPSF/ AC04 em complexos de inclusão e encapsulados em lipossomas.Unitermos: Espectrofotometria UV/análise quantitativa/validação de método. Derivados acridínicos/ determinação. Complexos de inclusão. Lipossomas.

show abstract

Spectrophotometric method for the determination, validation, spectroscopic and thermal analysis of diphenhydramine in pharmaceutical preparation

Cited by 20 publications

References 17 publications

Removal of diphenhydramine from water by swelling clay minerals

Removal of diphenhydramine from water by swelling clay minerals

Analytical Method Development by Solid Phase Extraction and High-Performance Liquid Chromatography for Diphenhydramine Quantification in Syrups

Validation of a UV-spectrophotometric analytical method for determination of LPSF/AC04 from inclusion complex and liposomes

Contact Info

Product

Resources

About