Validation of a method for the determination of zolpidem in human plasma using LC with fluorescence detection

Ring, Paula R; Bostick, J. M.

doi:10.1016/s0731-7085(99)00311-8

Cited by 36 publications

(29 citation statements)

References 4 publications

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“…ω1 type GABAA receptors are the α1 containing GABAA receptors and ω2 GABAA receptors are the α2, α3, α4, α5 and α6 containing GABAA receptors. ω1 GABAA receptors 5 are primarily found in the brain whereas ω2receptors 6 are primarily found in the spine.…”

Section: Melatoninmentioning

confidence: 99%

A Validated Rp-HPLC Method for the Determination of Melatonin and Zolpidem Tartarate in Bulk and Pharmaceutical Dosage Forms

Sattar¹,

Suneetha²

2018

Int. Res. J. Pharm.

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A new method was established for simultaneous estimation of Melatonin and Zolpidem Tartarate and by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Melatonin and Zolpidem Tartarate by using Hypersil BDS C18 column (250×4.6mm) 5.0µm, flow rate was 1.0ml/min, mobile phase ratio was (50:50 v/v) Potassium dihydrogen o-phosphate Buffer: Acetonitrite pH 4.3 (pH was adjusted with Ortho-phosphoric acid), detection wavelength was 235nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, Empower-software version-2. The retention times of Melatonin 2.60 mins and Zolpidem were found to be 3.31 mins. The % purity of Melatonin and Zolpidem Tartarate and was found to be 99.66% and 99.94% respectively. The system suitability parameters for Melatonin and Zolpidem Tartarate such as theoretical plates and tailing factor were found to be 3817 and 1.3, 4492, 1.1 and the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Melatonin and Zolpidem Tartarate was found in concentration range of 12µg-72µg and 20µg-120µg and correlation coefficient (r 2 ) was found to be 0.999 and 0.999, % recovery was found to be 95.0% and 105.0%, %RSD for repeatability was 0.095 and 0.087, % RSD for intermediate precision was 0.095 and 0.087 respectively. The precision study was precise, robust, and repeatable. LOD value was 0.7729 and 1.947 , and LOQ value was 2.3422 and 5.9026 respectively. Hence the suggested RP-HPLC.

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Section: Melatoninmentioning

confidence: 99%

A Validated Rp-HPLC Method for the Determination of Melatonin and Zolpidem Tartarate in Bulk and Pharmaceutical Dosage Forms

Sattar¹,

Suneetha²

2018

Int. Res. J. Pharm.

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“…Several methods have been described for 6-7, the determination of ZOL by UV spectrophotometry 8-9, stability indicating HPLC bulk drugs and human [10][11] plasma reported for the simultaneous estimation of…”

Section: Fig1: Chemical Structure Of (A) Melatonin and (B) Zolpidemmentioning

confidence: 99%

High-Performance Thin Layer Chromatographic Method for the Simultaneous Quantitation of Melatonin and Zolpidem in Tablet formulation

Venkatachalam¹,

Lalitha²

2014

Journal of Pharmaceutical Research

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A simple, accurate and precise densitometry method for the simultaneous estimation melatonin (MEL) and zolpidem (ZOL) in pharmaceutical dosage forms has been developed and validated. Separation of drugs was carried out using toluene: n-butanol: glacial acetic acid: water (1:4:2:2v/v/v/v) as mobile phase on precoated Silica Gel 60F plates. The densitometry evaluation of spot was carried out at 254 nm. The R 254 f value for MEL and ZOL were found to be 0.87±0.01 and 0.59±0.01 respectively. The method was validated with respect to linearity, accuracy, precision and robustness as per the International Conference on Harmonization (ICH) guidelines. The drug response with respect to peak area was linear over the concentration range 150-900 ng/spot and 250-1500 ng/spot for MEL and ZOL respectively, limit of detection and limit of quantitation were found to be 14.96 ng/spot and 45.60 ng/spot for MEL and 19.53 ng/spot and 59.24 ng/spot for ZOL. The percentage recovery of MEL and ZOL were found be 99.04-99.35% and 98.11-98.77% respectively. The % RSD values for (intra-day RSD 0.26-0.56% and inter-day RSD 0. 36-0.78 %for MEL and intraday RSD 0.18-0.31% and inter day 0.23-0.31% for ZOL). It was observed that the proposed HPTLC method could be used for efcient analysis and monitoring of the MEL and ZOL in combined tablet dosage forms.

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“…3,4) Many analytical methods have been published for the determination of zolpidem based on high-performance liquid chromatography (HPLC) combined with ultraviolet, 5) fluorescence 6,7) and with photodiode-array detection, 8) gas chromatography-nitrogen phosphorus detection, 9) gas chromatography-mass spectrometry, 10,11) capillary electrophoresis with laser-induced fluorescence detection 12) and radioimmunoassay. 13) However, to our knowledge no information about the electrochemical redox properties of zolpidem and its analytical application has appeared in the literature.…”

Section: Zolpidem (mentioning

confidence: 99%

Electrochemical Study of Zolpidem at Glassy Carbon Electrode and Its Determination in a Tablet Dosage Form by Differential Pulse Voltammetry

Radi

Bekhiet

Wahdan

2004

CHEMICAL & PHARMACEUTICAL BULLETIN

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Zolpidem ( Fig. 1), (N,N,6-trimethyl-2-(4-methylphenyl)-imidazole[1,2-a]pyridine-3-acetamide, is a non-benzodiazepine hypnotic drug with an imidazopyridine backbone, which acts in the brain principally at receptors of the w 1 -receptor subtype belonging to the g-aminobutyric acid-(GABA)ergic system. 1) Zolpidem is characterized by its fast onset of action and relatively short elimination half-life ranging between 1.4 and 4.5 h.2) For this reason bedtime administration carries a low risk of residual daytime sedative effects. 3,4) Many analytical methods have been published for the determination of zolpidem based on high-performance liquid chromatography (HPLC) combined with ultraviolet, 5) fluorescence 6,7) and with photodiode-array detection, 8) gas chromatography-nitrogen phosphorus detection, 9) gas chromatography-mass spectrometry, 10,11) capillary electrophoresis with laser-induced fluorescence detection 12) and radioimmunoassay. 13)However, to our knowledge no information about the electrochemical redox properties of zolpidem and its analytical application has appeared in the literature. The present study deals with the voltammetric oxidation behaviour of zolpidem on glassy carbon electrode and its determination by differential pulse voltammetry (DPV) in a tablet dosage form. ExperimentalReagents Zolpidem hemitartrate was kindly supplied by Amriya for Pharmaceutical Industries (Alexandria, Egypt) and was used without prior purification. Stilnox ® tablets were purchased from local pharmacies. Each tablet was labeled to contain 10 mg zolpidem hemitartrate. Methanol (Merck) was of HPLC grade; water was doubly distilled. All other chemicals were of analytical-reagent grade (Merck or Sigma) and were used as received.Zolpidem stock solutions were prepared daily by direct dissolution in methanol. Britton-Robinson buffers (0.04 M of each of acetic, o-phosphoric, and boric acids, adjusted to the required pH with 0.2 M sodium hydroxide solution) were used as supporting electrolytes.Apparatus The voltammetric measurements were performed using a PC controlled AEW2 analytical electrochemical workstation with ECprog3 electrochemistry software (Sycopel, U.K.) connected to C-2 stand with a three-electrode configuration: a glassy carbon (Fϭ3 mm) working electrode, an Ag/AgCl/3 M KCl reference electrode and a platinum wire counter electrode. OriginPro 7.0 software was used for the transformation of the initial signal. A CG 808 (Schott Geräte, Germany) digital pH meter with glass combination electrode served to carry out the pH measurements.Procedure. Recommended Procedure Ten milliliters of the electrolyte solution were transferred into the voltammetric cell. After measurement of the blank solution, the appropriate amount of zolpidem solution is added and the anodic potential sweep was carried under different operational parameters. All measurements were carried out at room temperature, and peak heights were evaluated by means of the tangent method. The electrode must be rinsed with methanol and deionized water prior to each...

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Validation of a method for the determination of zolpidem in human plasma using LC with fluorescence detection

Cited by 36 publications

References 4 publications

A Validated Rp-HPLC Method for the Determination of Melatonin and Zolpidem Tartarate in Bulk and Pharmaceutical Dosage Forms

A Validated Rp-HPLC Method for the Determination of Melatonin and Zolpidem Tartarate in Bulk and Pharmaceutical Dosage Forms

High-Performance Thin Layer Chromatographic Method for the Simultaneous Quantitation of Melatonin and Zolpidem in Tablet formulation

Electrochemical Study of Zolpidem at Glassy Carbon Electrode and Its Determination in a Tablet Dosage Form by Differential Pulse Voltammetry

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