Development and validation of a simple stability-indicating high performance liquid chromatographic method for the determination of miconazole nitrate in bulk and cream formulations

Zan, María Mercedes de; Cámara, Marı́a S.; Robles, Juan C.; Kergaravat, Silvina V.; Goicoechea, Héctor C.

doi:10.1016/j.talanta.2009.04.060

Cited by 27 publications

(8 citation statements)

References 17 publications

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“…In addition, there is a large number of articles demonstrating validation of LC-ESI-MS methods for practical analytical tasks with respect to certain validation guidelines such as FDA [68][69][70][71][72], ICH [73][74][75] Eurachem [76][77][78][79][80][81][82][83], EMA [84][85][86], IUPAC [87][88][89] or SANCO [90,91]. However, in most cases not all parameters are investigated.…”

Section: Practicalmentioning

confidence: 99%

Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part I

Kruve

Rebane

Kipper

et al. 2015

Analytica Chimica Acta

235

145

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This is the part I of a tutorial review intending to give an overview of the state of the art of method validation in liquid chromatography mass spectrometry (LC-MS) and discuss specific issues that arise with MS (and MS/MS) detection in LC (as opposed to the "conventional" detectors). The Part I briefly introduces the principles of operation of LC-MS (emphasizing the aspects important from the validation point of view, in particular the ionization process and ionization suppression/enhancement); reviews the main validation guideline documents and discusses in detail the following performance parameters: selectivity/specificity/identity, ruggedness/robustness, limit of detection, limit of quantification, decision limit and detection capability. With every method performance characteristic its essence and terminology are addressed, the current status of treating it is reviewed and recommendations are given, how to determine it, specifically in the case of LC-MS methods.

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Section: Practicalmentioning

confidence: 99%

Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part I

Kruve

Rebane

Kipper

et al. 2015

Analytica Chimica Acta

235

145

View full text Add to dashboard Cite

show abstract

“…Their principal advantages are separation efficiency; identification of almost any type of molecule present in a food sample; and depending of which technique is employed, it is possible to obtain very low detection limits for a wide range of analytes. Liquid chromatography, in particular HPLC (high performance liquid chromatography), can detect compounds such as aldehydes, proteins, amino acids, phenolic compounds and carbohydrates (Ball 1990;De Zan et al, 2009;Francisco & Resurreccion 2009;Rubio Barroso et al, 2006;Schultheiss et al, 2000;Thoma et al, 2006). On the other hand, GC (gas chromatography) is more suited to the analysis of volatile or semi-volatile compounds; some substances must be extracted from the food sample, e.g., fatty acids from triglycerides; but others, such as alcohols, can be injected directly into the column (Petrovic et al, 2010;.…”

Section: Methods Based On Chromatographic Techniquesmentioning

confidence: 99%

Procedures of Food Quality Control: Analysis Methods, Sampling and Sample Pretreatment

Ornelas‐Soto¹,

Barbosa-Garcı́a²,

López-de-Alba³

2011

Quality Control of Herbal Medicines and Related Areas

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“…The literature survey revealed that a few analytical methods have been reported for the determination of the studied drugs in pure drug, pharmaceutical dosage forms and biological samples using liquid chromatography either in single or in combined forms [3][4][5], electrochemical methods [6,7], spectroflourimetric methods [3,8] and spectrophotometric methods [9][10][11][12][13][14]. Visible spectrophotometry, because of simplicity and cost effectiveness, sensitivity and selectivity, fair accuracy, precision and available in most quality control laboratories, have remained competitive in an area of chromatography techniques for pharmaceutical analysis.…”

Section: Introductionmentioning

confidence: 99%

Spectrophotometric methods based on charge transfer complexation reaction for the determination of some antifungal drugs in pure and dosage forms

Gouda¹,

Sheikh²,

Amin³

et al. 2017

Bull. Chem. Soc. Eth.

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ABSTRACT. Charge transfer complexes of some antifungal drugs fluconazole (FLU), sertaconazole nitrate (SER) and miconazole nitrate (MCO) as electron donor with the σ-acceptor iodine (I2) and 2,3-dichloro-5,6-dicyano-p-benzoquinone (DDQ), p-chloranilic acid (p-CLA) and 7,7,8, as π-acceptors in acetonitrile were investigated. The formation of the colored charge-transfer complexes were utilized in the development of simple, rapid and accurate spectrophotometric methods for the analysis of the cited drugs in pure forms and pharmaceutical formulations at 365 nm for MCO and SER using I2 method, at 460 nm for FLU and SER using DDQ method, at 535 and 530 nm for FLU and SER, respectively, using p-CLA method and at 842 nm for MCO and SER using TCNQ method. The optimum experimental conditions have been studied carefully and optimized. Beer's law was obeyed over the concentration ranges of 2.0-28, 10-240 and 2.0-160 µg mL −1 for MCO, FLU and SER, respectively, with good correlation coefficients (0.9996-0.9999). Molar absorpitivity, Sandell sensitivity, relative standard deviation, limit of detection and quantification were calculated. The obtained data refer to high accuracy and precision of the proposed method. The obtained results were confirmed by inter and intra-day accuracy and precision with percent recovery of 99.1-100%, 99.3-101% and 99.1-101% for MCO, FLU and SER, respectively. These data were compared with those obtained using official methods for the determination of the cited drugs. The proposed methods were applied successfully for simultaneous determination of the cited drugs in their pharmaceutical formulations with good accuracy and precision and without interferences from common additives.

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Development and validation of a simple stability-indicating high performance liquid chromatographic method for the determination of miconazole nitrate in bulk and cream formulations

Cited by 27 publications

References 17 publications

Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part I

Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part I

Procedures of Food Quality Control: Analysis Methods, Sampling and Sample Pretreatment

Spectrophotometric methods based on charge transfer complexation reaction for the determination of some antifungal drugs in pure and dosage forms

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