Quantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography

Dispas, Amandine; Desfontaine, Vincent; Andri, Bertyl; Lebrun, Philippe; Kotoni, Dorina; Clarke, Adrian; Guillarme, Davy; Hubert, Philippe

doi:10.1016/j.jpba.2016.11.039

Cited by 50 publications

(13 citation statements)

References 21 publications

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“…The dosage range validated was 50 to 150% (corresponding to 0.3% concentration level), and LODs were measured as close to 0.5 g/ml. In order to quantify salbutamol impurities, the SFC approach proposed in this study could be provided as an appropriate rapid alternative to the EP LC method (Dispas et al, 2017).…”

Section: Pro Iling Of Impurities By Supercritical Luid Chromatographymentioning

confidence: 99%

Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

Nishanth¹,

Akhila²,

Tengli³

et al. 2020

ijrps

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Impurity profiling is known to identify, classify and measure both the identified and non-identified contamination present on the medicinal product. Unwanted chemicals which remain or are created during the formulation of medicinal products are pharmaceutical impurities. Impurity profiling helps in the detection, recognition and quantification in bulk products and pharmaceutical formulations of various types of impurities, as well as residual solvents. It is the simplest way to distinguish consistency and stability of bulk drugs and medication formulations. As analytical methodology has developed rapidly, it is essential to consider with their solutions problems related to impurities of drug substances and drug products. Various regulatory agencies including ICH, USFDA, Canadian Drug and Health Agencies stress the criteria for purity and for detecting impurities in active pharmaceutical materials, even in small quantities, as the presence of impurities, may have an effect on pharmaceutical products ’ efficacy and health. Therefore, the study focuses on various analytical methods for identification and quantification of impurities in pharmaceutical products to clarify the need for impurity profiling on drug products in pharmaceutical research. To drug regulators, the product substance’s impurity profile is a reliable fingerprint to prove that the manufacturing process of bulk drug substances is consistent in quality. The study gives a short summary of recent technical developments in the profiling of pharmaceutical products including pharmaceutical active ingredients as well as pharmaceutical products during 2013-2017. Such recent trends in the profiling of impurities have been addressed in the study. This focuses specifically on a thorough update on various analytical techniques, including hyphenated methods to define and measure thresholds in specific pharmaceutical matrices of impurities and degradants.

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Section: Pro Iling Of Impurities By Supercritical Luid Chromatographymentioning

confidence: 99%

Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

Nishanth¹,

Akhila²,

Tengli³

et al. 2020

ijrps

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“…LC method involving ion-pairing reagents. 57 The separation was seven times faster (7 vs. 50 min) and was validated according to ICH Q2 guidelines using an accuracy profile approach. Then, the authors performed an inter-laboratory study, involving 19 participating laboratories across four continents and nine different countries, on the same sample to assess the reproducibility of the method and evaluate whether or not this chromatographic technique could become a reference method for quality control (QC) laboratories.…”

Section: Supercritical Fluid Chromatography Of Drugsmentioning

confidence: 99%

Recent Advances in Chromatography for Pharmaceutical Analysis

et al. 2018

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“…Many methods have been reported for the determination of SBS, these include HPLC, Reverse phase high performance liquid chromatography (4,6,7,8) , achiral supercritical fluid chromatography (9), ion pair liquid chromatography (10),atomic absorption spectrophotometric (11), Differential pulse voltammetric (12), titrimetric method (13), continuous/stopped flow injection method (14), spectrophotometric methods (1, 15,16), first-order derivative spectroscopy (17) and Second Order Derivative method (18). The purpose of the present study is to develop a simple and sensitive method for the determination of salbutamol sulphate in pharmaceutical preparations using diazotization coupling reaction.…”

Section: Figure 1 the Chemical Structure Of Salbutamolmentioning

confidence: 99%

Spectrophotometric Assay of Salbutamol Sulphate in Pharmaceutical Preparations by Coupling with Diazotized ρ-bromoaniline

Tamathir¹

2019

Baghdad Sci.J

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In this research, salbutamol sulphate (SAS) has been determined by a simple, rapid and sensitive spectrophotometric method. Salbutamol sulphate in this method is based on the coupling of SAS with diazotized ρ- bromoaniline reagent in alkaline medium of Triton X-100 (Tx) to form an orange azo dye which is stable and water-soluble. The azo dye is exhibiting maximum absorption at 441 nm. A 10 - 800 µg of SAS is obeyed of Beer's law in a final volume of 20 ml, i.e., 0.5- 40 ppm with ε, the molar absorptivity of 48558 L.mol-1.cm-1 and Sandell's sensitivity index of 0.01188 µg.cm-2. This new method does not need solvent extraction or temperature control which is well applied to determine SAS in different types of pharmaceutical preparations.

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Quantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography

Cited by 50 publications

References 21 publications

Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

Recent Advances in Chromatography for Pharmaceutical Analysis

Spectrophotometric Assay of Salbutamol Sulphate in Pharmaceutical Preparations by Coupling with Diazotized ρ-bromoaniline

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