Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup

A stability-indicating high-performance liquid chromatography procedure has been developed for the determination of alizapride (AL) and its main degradation products alizapride carboxylic acid (AL-CA) and alizapride N-oxide (AL-NO2) in drug substance and product. The method was developed based on forced degradation data obtained by HPLC-MS analysis. Indeed AL underwent chemical degradation by acid/base catalyzed hydrolysis and oxidation the main degradation products being AL-CA and AL-NO2 respectively. The separation and quantisation were achieved on a 150-mm reverse phase column with a hydrophilic linkage between silica particles and hydrophobic alkyl chains. The mobile phase was constituted (flow rate 1.5mLmin(-1)) of eluant A: aqueous acetate buffer (pH 4.0; 20mM) and eluant B: CH(3)OH using a gradient elution and detection of analytes at 225nm. The method showed good linearity for the AL, AL-CA, AL-NO2 mixture in the 25-75, 1-15 and 1-15microgmL(-1) ranges respectively, being all the square of the correlation coefficients greater than 0.999. The precision, determined in terms of intra-day and inter-day precisions and expressed as RSDs were 0.8, 1.3 and 2.1% and 1.0, 1.7, 4.8% for AL, AL-CA and AL-NO2 respectively. The method demonstrated also to be accurate; indeed the average recoveries, at 100% and 0.2% of the target assay concentration, were 100.5, 98.6, and 96.8% for AL, AL-CA and AL-NO2 respectively. The robustness was also evaluated by variations of mobile phase composition and pH. Finally, the applicability of the method was evaluated in commercial dosage form analysis as well as in stability studies.

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“…The system suitability parameters resolution (Rs), area repeatability and asymmetry factor (As) were calculated as previously reported [11].…”

Section: Preparation Of Analytical Samplesmentioning

confidence: 99%

Development and validation of a stability-indicating HPLC-UV method for the determination of alizapride and its degradation products

Tamaro¹,

Aprile²,

Giovenzana³

et al. 2010

Journal of Pharmaceutical and Biomedical Analysis

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“…Even this approach is being extended to drug combinations [5,6], to allow accurate and precise quantitation of multiple drugs, their degradation products, and interaction products, if any.…”

Section: Introductionmentioning

confidence: 99%

ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products

Kumar

Bhutani

Singh

2007

Journal of Pharmaceutical and Biomedical Analysis

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“…The literature collected reveals that there are many analytical methods reported of the estimation of parabens alone and together with other drugs or excipients by high-performance liquid chromatography (HPLC), ultra performance liquid chromatography, capillary electrophoresis and gas chromatography mass spectrometry in cosmetics, pharmaceuticals, and environmental samples [10][11][12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Central Composite Design to Develop a Robust Reversed-Phase Thin-Layer Chromatography/Densitometry Method for Quantification of Parabens in Cosmetic Preparations

Kavitha

Lakshmi

2017

Asian J Pharm Clin Res

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Objective: The current study was framed with a view to develop a simple, sensitive and a rapid reversed-phase thin-layer chromatography (RP-TLC)/ densitometry method for quantification of parabens (methyl, ethyl, propyl, and butyl) in various cosmetic preparations available in local market. Moreover, robustness testing was planned to be performed applying a central composite design (CCD). Methods:The desired chromatographic separation was achieved on RP-TLC/densitometry plates precoated with Silica gel 60 GF 254 on aluminum sheet, employing methanol:toluene:acetonitrile:glacial acetic acid as mobile phase in the ratio of 3:5:1.8:0.2 v/v/v/v and detection was carried out at 256 nm. Results:The mobile phase used gave an excellent resolution of all the four separated parabens. The method was found linear over a wide range of 6.25-400 ng/spot. The optimized method was validated by measuring various validation parameters. CCD was employed to check the robustness of the method at three-factor levels. The developed and optimized method was used to quantify parabens in 30 different cosmetic products procured from local market. Conclusion:The proposed and developed RP-TLC/densitometry method can be applied for routine analysis of all the parabens in cosmetic products and can also be extended to the analysis in pharmaceuticals and food products.

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Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup

Cited by 56 publications

References 18 publications

Development and validation of a stability-indicating HPLC-UV method for the determination of alizapride and its degradation products

Development and validation of a stability-indicating HPLC-UV method for the determination of alizapride and its degradation products

ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products

Central Composite Design to Develop a Robust Reversed-Phase Thin-Layer Chromatography/Densitometry Method for Quantification of Parabens in Cosmetic Preparations

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