HPLC determination of chlorhexidine gluconate and p-chloroaniline in topical ointment

Havlíková, Lucie; Matysová, Ludmila; Nováková, Lucie; Hájková, Renata; Solich, Petr

doi:10.1016/j.jpba.2006.09.037

Cited by 37 publications

(19 citation statements)

References 22 publications

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“…The limit of detection (LOD) and limit of quantitation (LOQ) were calculated from linearity data according to ICH [22]:LOD = 3.3* (SD/S) and LOQ = 10 * (SD/S). TheLOD was found to be 0.97626µg/mland 0.01151 µg/ml for CHD and pCA, respectively, while the LOQ valueswere 3.2541 µg/mland 0.038389 µg/ml, respectively.…”

Section: Limit Of Detection (Lod) and Limit Of Quantitation (Loq)mentioning

confidence: 99%

“…It is readily absorbed through the skin and it may act as a sensitizer [10]. However, as pCA is the principal product of degradation of CHD and toxic with actual recommend maximum limit of genotoxic impurity [11], it is important to quantify pCA in CHD solution.CHD and pCAwasdetermined using several methodologies such as high performance liquid chromatography [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27],gas chromatography-mass (GC-MS) [28][29][30][31][32][33][34] Working standards of CHD and pCA, finished productsand excipientswere supplied from Yamani Medical Products. Methanol and Acetic acid were HPLCgrade(Scharlau Spain).…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of a simple, fast, isocratic stability indicating RP-HPLC-UV method for the determination of chlorhexidine and its impurity para-chloroaniline in bulk and finished product

Mohammed¹,

Aziz²

2017

IOSRPHR

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Abstract:-A simple, isocraticRP HPLC-UV method was developed for the simultaneous determination of chlorhexidine (CHD) and p-Chloroaniline (pCA) inchlorhexidine mouth rinses. An excellent separation obtainedbyC18 column (200mm × 4.6 mm, 3μm). Mobile phasewas acetate buffer:methanol in a 45:55 ratio,flowrate was 1.0 ml/min. Both ingredient and an impuritywere detected at 254 nm,injection volume was 20µl and the analysis temperature was room temperature.Resolution4.7,retention times was3.1min and 5.7 min for pCAand CHD respectively. The proposed method was testedforsystem suitability, linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits. The linearity range was40-160µg/ml forCHD and0.3-1.2 µg/ml forpCA.The correlation coefficient of the regression line was 1.000 for both components. Method robustness was tested under nine different conditions using sampleswith a known content. For CHD, the mean of the nine assays was 99.95% andthe RSD was 0.16%. ForpCA, the mean of the nine assays was 99.98% and the RSD was 0.24%. The results show that this is a simple method that can be applied to the analysis of Chlorhexidineproductswith satisfactory degrees of accuracy and precision. Due to the selected optimized conditions, this method can be used with the minimum requirements of an isocratic HPLC system.

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Section: Limit Of Detection (Lod) and Limit Of Quantitation (Loq)mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and validation of a simple, fast, isocratic stability indicating RP-HPLC-UV method for the determination of chlorhexidine and its impurity para-chloroaniline in bulk and finished product

Mohammed¹,

Aziz²

2017

IOSRPHR

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“…The CHX molecule itself poses a systemic risk because it can be decomposed into reactive by-products such as PCA [13,14]. The PCA is generated by the hydrolysis of CHX as a function of time, alkaline pH and heat [13], and the presence of PCA has been detected in solutions of CHX [13,14]. In an in vitro study the visible light spectrophotometry did not allow to identify that the molecule generated when activating the 2% CHX with the endodontic ultrasound was Parachloroaniline [15].…”

Section: Introductionmentioning

confidence: 99%

Effect of Ultrasound on the Formation of Parachloroaniline Study in ex-vivo

Yévenes¹,

Neira²,

Parada³

et al. 2017

J Clin Exp Orthop

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“…For pharmaceutical products that contain CHX, several physicochemical methods are presented, such as HPLC (Gavlick, 1992;Há, Cheung, 1996;Izumoto et al, 1997;Havlíková et al, 2007), solidphase extraction with UV spectrophotometry (Bonazzi et al, 1995), gas-liquid chromatography (Miribel et al, 1983), and capillary electrophoresis (Abad-Villar et al, 2006).…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a microbiological assay for determination of chlorhexidine digluconate in aqueous solution

Fiorentino

Corrêa

Salgado

2013

Braz. J. Pharm. Sci.

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Chlorhexidine (CHX) is a broad-spectrum antiseptic that is used in many topical pharmaceutical formulations. Because there is no official microbiological assay reported in the literature that is used to quantify CHX, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method for the dosage of chlorhexidine digluconate (CHX-D) in an aqueous solution. The assay is based on the inhibitory effect of CHX-D upon the strain of Staphylococcus aureus ATCC 25923, which is used as the test microorganism. The design 3x3 parallel-line model was used. The results were treated statistically by analysis of variance (ANOVA), and they were excellent in terms of linearity (r = 0.9999), presenting a significant regression between the zone diameter of growth inhibition and the logarithm of the concentration within the range of 0.5 to 4.5%. The results obtained were precise, having relative standard deviations (RSD) for intra-day and inter-day precision of 2.03% and 2.94%, respectively. The accuracy was 99.03%. The method proved to be very useful and appropriate for the microbiological dosage of CHX-D in pharmaceutical formulations; it might also be used for routine drug analysis during quality control in pharmaceutical industries.Uniterms: Agar diffusion. Antiseptic. Chlorhexidine. Microbiological assay. Quality control. Validation.Clorexidina (CHX) é um antisséptico com amplo espectro de ação utilizada em muitos tipos de preparações farmacêuticas para uso tópico. Uma vez que não há na literatura ensaio microbiológico oficial para quantificar a clorexidina, este trabalho objetivou o desenvolvimento e validação de um ensaio microbiológico simples, sensível, exato e reprodutível, por difusão em ágar, para doseamento de digliconato de clorexidina (CHX-D) em solução aquosa. O ensaio é baseado no efeito da inibição de Staphylococcus aureus ATCC 25923, utilizado como microorganismo teste, pela CHX-D. Utilizouse o delineamento 3x3. Os resultados foram verificados estatisticamente pela análise de variância (ANOVA) e apresentaram excelente linearidade (r = 0,9999), demonstrando que o método segue o modelo linear com regressão significativa entre o diâmetro da zona de inibição e o lagaritmo da concentração no intervalo de 0,5 a 4,5%. Os resultados obtidos foram precisos apresentando desvio padrão relativo (DPR) para precisão intra-dia de 2,03% e DPR para precisão inter-dias de 2,94%. A exatidão foi 99,03%. O método provou ser muito útil e apropriado para doseamento microbiológico da CHX-D em formas farmacêuticas e pode ser empregado para análise desta substância no controle de qualidade em indústrias farmacêuticas.Unitermos: Difusão em ágar. Antisséptico. Clorexidina. Ensaio microbiológico. Controle de qualidade. Validação.

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HPLC determination of chlorhexidine gluconate and p-chloroaniline in topical ointment

Cited by 37 publications

References 22 publications

Development and validation of a simple, fast, isocratic stability indicating RP-HPLC-UV method for the determination of chlorhexidine and its impurity para-chloroaniline in bulk and finished product

Development and validation of a simple, fast, isocratic stability indicating RP-HPLC-UV method for the determination of chlorhexidine and its impurity para-chloroaniline in bulk and finished product

Effect of Ultrasound on the Formation of Parachloroaniline Study in ex-vivo

Development and validation of a microbiological assay for determination of chlorhexidine digluconate in aqueous solution

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