Simple and sensitive method for determination of metronidazole in human serum by high-performance liquid chromatography

Galmier, Marie-Josèphe; Frasey, A.M.; Bastide, M.; Beyssac, Eric; Petit, J.; Aiache, Jean-Marc; Lartigue-Mattei, C.

doi:10.1016/s0378-4347(98)00443-5

Cited by 41 publications

(23 citation statements)

References 11 publications

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“…The mean pharmacokinetic parameters for the brands of metronidazole and tinidazole tablets are summarized in Table III. The pharmacokinetic parameters obtained in this study are in accordance with those reported by some other researchers [13,25]. The mean AUC 0-48 , AUC 0-∞ , and C max of the test products (metronidazole, tinidazole) were compared with those of respective references (Flagyl®, Fasigyn®).…”

Section: Resultssupporting

confidence: 88%

“…The plasma half-life of metronidazole is 8 h but tinidazole has significantly longer elimination half-life of around 14 h [5]. Several analytical methods have been described for determination of metronidazole either alone or in combination with various drugs in dosage forms or in biological fluids including spectrophotometry [6,7], non-aqueous titration [8], voltammetry [9], electrophoresis [10], and high performance liquid chromatographic (HPLC) methods [11][12][13][14][15][16][17][18][19]. Measurement of tinidazole using HPLC has also been reported [20][21][22][23].…”

Section: Introductionmentioning

confidence: 99%

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Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

Emami¹,

Rezazadeh²

2013

Acta Chromatographica

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Summary.A simple, rapid, and sensitive reversed-phase HPLC method was developed and validated for determination of metronidazole and tinidazole in human plasma samples under identical chromatographic conditions. This method involves liquid-liquid extraction using chloroform: isopropylalcohol (95:5). Chromatographic separation was performed using a μ-bondapack C18 (250 mm × 4.6 mm) column. The mobile phase consisted of potassium dihydrogen phosphate solution (0.005 M)/acetonitrile (80/20 v/v). The final pH of the mobile phase was adjusted to 4 ± 0.1 with orthophosphoric acid. The calibration curves were linear over the concentration range 0.1-15 μg/mL for metronidazole and tinidazole with the detection limit of 30 ng/mL. Within-and between-day precision and accuracy did not exceed 9.83% and 10.48%, respectively. Metronidazole and tinidazole were found to be stable in plasma samples with no evidence of degradation during 3 freeze-thaw cycles and 3 months storage in −70 °C. The current validated bio-analytical method was finally applied in bioequivalence studies of two different metronidazole and tinidazole products according to a standard two-way cross-over design with a two-week washout period. No statistically significant difference was observed between the logarithmically transformed AUC 0-∞ and C max values. Therefore, generic products were considered bioequivalent with those of standards which could be used interchangeably.

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Section: Resultssupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

Emami¹,

Rezazadeh²

2013

Acta Chromatographica

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“…MET has been determined by several methods involving spectrophotometry [23][24][25][26] and HPLC. [27][28][29][30][31][32] MET in intravenous admixture with CIP was determined by first-derivative spectrophotometry 33) and LC. 34) Literature reports only one article for the simultaneous determination of CIP and MET in tablet form by the same authors of the present work.…”

Section: )mentioning

confidence: 99%

Validated Spectrophotometric Methods for the Simultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in Tablets

Mahrouse

Elkady

2011

CHEMICAL & PHARMACEUTICAL BULLETIN

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Regular ArticleCiprofloxacin (CIP, Fig. 1a) [1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazinyl)-quinolone-3-carboxylic acid] belongs to the second generation of fluoroquinolone antibacterial agents. These quinolones are effective against Grampositive and Gram-negative bacteria through inhibiting bacterial DNA gyrase (topoisomerase), the enzyme responsible for maintaining the superhelical twists in the bacterial DNA, leading to inhibition of bacterial DNA synthesis.1) Similar to other fluoroquinolones, CIP has shown clinical efficacy in the treatment of a wide range of systemic infections such as urinary tract, respiratory, gastrointestinal and cutaneous infections. Because of its low toxicity, very wide spectrum of antibacterial effect and low ability to cause bacterial resistance, CIP has been widely used in clinical practice.2) Metronidazole (MET, Fig. 1b) is used as an antiprotozoal, antiamebic and antibacterial drug.3) It is chemically designated as 2-methyl-5-nitroimidazole-1-ethanol. Since CIP has a reduced activity against anaerobic pathogens, CIP and MET are coformulated together in pharmaceutical dosage forms for the treatment of mixed aerobic/anaerobic infections. 4)A survey of literature has revealed several analytical methods for the determination of CIP in pharmaceutical dosage form and biological fluids, including spectrophotometry, [5][6][7][8] spectrofluorimetry, 9-11) HPLC, 12-16) capillary electrophoresis 17,18) and HPTLC. 19) CIP in admixtures with MET and ampicillin has been determined by NMR. 20) Recently, HPLC methods either with fluorescence detection or coupled with mass spectrometry (LC/MS) for determination of ciprofloxacin in human plasma 21,22) have also been published. MET has been determined by several methods involving spectrophotometry [23][24][25][26] and HPLC. [27][28][29][30][31][32] MET in intravenous admixture with CIP was determined by first-derivative spectrophotometry 33) and LC. 34) Literature reports only one article for the simultaneous determination of CIP and MET in tablet form by the same authors of the present work. In this article, a reversed phase ion-pair HPLC and TLC densitometry have been adopted for the simultaneous determination of both drugs in tablets.35) However, due to lack of such equipments in many resources-limited countries and the high costs of HPLC grade solvents and columns, alternative methods are needed to facilitate and increase the speed of analysis, with relatively few costs. To the best of the authors' knowledge, no previous article concerning simultaneous spectrophotometric determination of the two drugs was published. Spectrophotometry continues to be very popular, because of its simplicity, versatility and low cost. Therefore, the aim of the present work was to develop and validate different UV spectrophotometric and chemometric techniques for the simultaneous determination of CIP and MET in tablets without previous separation. Both derivative and derivative ratio spectrophotometry are useful technique for resolving two overlapping...

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“…CIP in admixtures with MET and ampicillin has been determined by NMR [18]. MET has been analyzed by spectrophotometry [19][20][21][22] and HPLC [23][24][25][26][27][28]. MET in intravenous admixture with CIP has been determined by first-derivative spectrophotometry [29] and LC [30].…”

Section: Introductionmentioning

confidence: 99%

Reversed-Phase Ion-Pair HPLC and TLC-Densitometric Methods for the Simultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in Tablets

Elkady

Mahrouse

2011

Chromatographia

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Two methods are described for the simultaneous determination of ciprofloxacin HCl (CIP) and metronidazole (MET) in binary mixture. The first method was based on the ion-pair liquid chromatographic separation of the two drugs on reversed-phase, lBondapak C 18 column (250 mm 9 4.6 mm, 10 lm) Waters. The mobile phase consisted of monobasic potassium phosphate (50 mM, pH 3, adjusted with phosphoric acid) and acetonitrile (65:35, v/v) containing sodium octane sulphonate (50 mM). Flow rate of 1.2 mL min -1 was applied. Quantitation was achieved with UV detection at 280 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 3-180 and 15-180 lg mL -1 for CIP and MET, respectively. The second method was based on the TLC separation of the two drugs followed by densitometric measurements of their bands at 280 nm. The separation was carried out on silica gel 60 F 254 plates, using acetonitrile, ammonia, methanol, methylene chloride and hexane (1.3:1.1:2.0:3.0:1.0, v/v) as developing system. The linear regression analysis data were used for the regression line in the range of 1.5-10 lg band -1 for CIP and MET. The two proposed methods were successfully applied to the determination of both drugs in laboratory prepared mixtures and in commercial tablets. The optimized methods proved to be specific, robust and accurate for the quality control of the cited drugs in pharmaceutical preparation.

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Simple and sensitive method for determination of metronidazole in human serum by high-performance liquid chromatography

Cited by 41 publications

References 11 publications

Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

Validated Spectrophotometric Methods for the Simultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in Tablets

Reversed-Phase Ion-Pair HPLC and TLC-Densitometric Methods for the Simultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in Tablets

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