Coupling of TLC and UV-measurement for quantification of naproxen and its main metabolite in urine

Abdel-Moety, Ezzat M.; Al‐Obaid, Abdulrahman M.; Jado, Ahmad I.; Lotfi, E. A.

doi:10.1007/bf03190090

Cited by 11 publications

(2 citation statements)

References 6 publications

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“…Intensive increase developing a new drug formulation confirms that there is a big need to find a reliable, selective, sensitive, as well as cost-effective analytical method suitable for accelerated stability measurements of available pharmaceutical products. Following on our previous papers [15][16][17][18][19] and those prepared by other authors [6,[20][21][22][23]. It is well known that from all analytical methods used, thin-layer chromatography combined with densitometry (TLC-densitometry) is still simple and cost-effective stability indicating method worldwide used in pharmaceutical analysis of various active ingredients, like for example naproxen.…”

Section: Introductionmentioning

confidence: 99%

Rapid TLC with Densitometry for Evaluation of Naproxen Stability

2020

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The purpose of the work was to develop such chromatographic conditions that allowed to separate as many naproxen degradation products as possible. In order to follow this process, thin-layer chromatography (TLC) coupled with densitometry and spectrodensitometry was used. A forced degradation study was performed using an ethanolic solution of naproxen spotted on silica gel plates, existing in the form of an aqueous solution at various pH values, and as solution prepared in saline and in hydrogen peroxide. Degradative effect of UV light on naproxen was watched in the context of naproxen spotted on plates precoated with silica gel and exposed to UV light, and also for its solution treated with UV light. However, the solution of naproxen prepared in water at pH ≈ 2.60 undergoes the largest changes as the results of its exposure to UV light during 10 h. Stressed samples of naproxen were analyzed by using a new and well validated TLC procedure including toluene (TOL)—acetone (ACE)—chloroform (CHL) (2:5:12, v/v/v) as mobile phase A and glacial acetic acid (AcOH)—n-hexane (Hex)—acetone (ACE)-(0.10:10:10, v/v/v) as mobile phase B. As the newly developed TLC-densitometric method can effectively separate the substances about pharmaceutical significance from products of its degradation, which are formed as a result of stress studies, is considered to be a good alternative and important tool in routine quality control and stability testing of naproxen in pharmaceutical formulations. These results indicate that proposed TLC-densitometric method is cost-effective, rapid, specific, accurate, and precise. This TLC procedure is comparable to HPLC and UPLC method in terms of detection the number of degradation products of naproxen. In addition, it realizes the criterion of linearity. A major advantage and novelty of proposed method is its low cost and ability to analyze examined drug and all degradation products simultaneously, including those which can be observed under intensive UV radiation exposure of naproxen solution which are not described by previous HPTLC studies available in the literature.

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Section: Introductionmentioning

confidence: 99%

Rapid TLC with Densitometry for Evaluation of Naproxen Stability

2020

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“…(Runkel et al, 1972a(Runkel et al, ,b, 1973(Runkel et al, , 1974(Runkel et al, , 1976(Runkel et al, , 1978Weber et al, 1981), t.l.c. (Abdel-Moety et al, 1988) and mass fragmentography (G0tzsche et al, 1983;Larssen & Marinelli, 1981). H.p.l.c.…”

Section: Introductionunclassified

The pharmacokinetics of naproxen, its metabolite O‐desmethylnaproxen, and their acyl glucuronides in humans. Effect of cimetidine.

Vree

Biggelaar-Martea

Wissen

et al. 1993

Brit J Clinical Pharma

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Zuid 8, 6525 GA Nijmegen 3Dotulabs, Sint Annastraat 85, 6524 EJ Nijmegen and 4FarmaResearch Snelliusstraat 6, 6533 NV Nijmegen, The Netherlands 1 The pharmacokinetics of 500 mg naproxen given orally were described in 10 subjects using a direct h.p.l.c. analysis of the acyl glucuronide conjugates of naproxen and its metabolite 0-desmethylnaproxen. 2 The mean elimination half-life of naproxen was 24.7 ± 6.4 h (range 7 to 36 h). 3 Naproxen acyl glucuronide accounted for 50.8 ± 7.3% of the dose recovered in the urine, its isomerised conjugate isoglucuronide for 6.5 ± 2.0%, 0-desmethylnaproxen acyl glucuronide for 14.3 ± 3.4%, and its isoglucuronide for 5.5 ± 1.3%. Naproxen and 0-desmethylnaproxen were excreted in negligible amounts (< 1%). 4 Even though the urine pH of the subjects was kept acid in order to stabilize the acyl glucuronides, isomerisation took place in blood. 5 The extents of plasma binding of the unconjugated compounds were 98% (naproxen) and 100% (0-desmethylnaproxen), while naproxen acyl glucuronide binding was 92%; that of its isomer isoglucuronide 66%. 0-desmethylnaproxen acyl glucuronide was 72% bound and its isoglucuronide was 42% bound. 6 Cimetidine (400 mg twice daily) decreased the t',, of naproxen by 39-60% (mean 47.3 + 11.5%; P = 0.0014) from 24.7 ± 6.4 h to 13.2 ± 1.0 h. It increased (10%) the urinary recovery of naproxen acyl glucuronide (P = 0.0492). The urinary recoveries of naproxen isoglucuronide and 0-desmethylnaproxen acyl glucuronide remained unchanged.

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Spectrophotometric quantification of astemizole and its demethylated metabolite in urine after TLC separation

Al‐Deeb

Abdel-Moety

Bayomi

et al. 1992

European Journal of Drug Metabolism and Pharmacokinetics

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The coupling of TLC and UV measurement for determination of astemizole and its main metabolite, O-demethylated derivative, in urine has been investigated. The metabolite like the drug absorbs maximally at almost the same wavelengths, which makes their simultaneous UV determination in biological fluids quite inapplicable. TLC separation on silica gel F254 utilizing chloroform/methanol (85:15, v/v) achieved the best fractionation of the two compounds from the matrix-components of urine. Concentration levels of 0.5-140 micrograms/ml (ppm) in worked-up sample could be reached by adopting the spectrophotometric measurements at 286 nm for ethanolic extracts of the silica layers carrying each individual compound against a blank silica. Varying levels of the intact drug and its phenolic primary metabolite could be accurately traced in urine samples following a 10 mg single oral dose (approximately 12.5 micrograms/kg) after different time intervals up to 12 h. Synthetic preparation of the metabolite by demethylating astemizole is mentioned and its physicochemical characterization is briefly discussed.

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Coupling of TLC and UV-measurement for quantification of naproxen and its main metabolite in urine

Cited by 11 publications

References 6 publications

Rapid TLC with Densitometry for Evaluation of Naproxen Stability

Rapid TLC with Densitometry for Evaluation of Naproxen Stability

The pharmacokinetics of naproxen, its metabolite O‐desmethylnaproxen, and their acyl glucuronides in humans. Effect of cimetidine.

Spectrophotometric quantification of astemizole and its demethylated metabolite in urine after TLC separation

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