Bioanalytical Validated LC-MS Method for Determination of Naproxen in Human Plasma (original) (raw)
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Determination of naproxen in human plasma by GC–MS
Journal of Separation Science, 2014
This paper describes a GC–MS method for the determination of naproxen in human plasma. Naproxen and internal standard ibuprofen were extracted from plasma using a liquid–liquid extraction method. Derivatization was carried out using N‐methyl‐N‐(trimethylsilyl)trifluoroacetamide. The calibration curve was linear between the concentration range of 0.10–5.0 μg/mL. Intra‐ and interday precision values for naproxen in plasma were <5.14, and accuracy (relative error) was better than 4.67%. The extraction recoveries of naproxen from human plasma were between 93.0 and 98.9%. The LOD and LOQ of naproxen were 0.03 and 0.10 μg/mL, respectively. Also, this assay was applied to determine the pharmacokinetic parameters of naproxen in six healthy Turkish volunteers who had been given 220 mg naproxen.
A concise review on analytical profile of naproxen
IP innovative publication pvt. ltd, 2019
Naproxen (NAP) is a Non-steroidal anti-inflammatory drugs (NSAID) used in the treatment of pain or inflammation caused by situations such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. Nap is available in isolated dosage from with various similar anti-inflammatory drugs, esomeprazole, pantoprazole, paracetamol, ranitidine, sumatriptan and ibuprofen. The present exploration evaluates the various method for analysing of NAP in bulk drugs and formulated products. A summarizing review characterizes the gathering and conversation of about more than 62 analytical methods which includes HPLC, HPTLC, UV-Spectrophotometry, capillary electrophoresis, electrochemical methods. HPLC technique are provided in Table03 and Table 04 for NAP alone and combination, including parameters such as matrix, stationary phase, mobile phase, wavelength detection etc. and HPTLC methods are reported in Table 05 with parameters like stationary phase, mobile phase combination, R F etc. Method of UV-Spectrophotometry applied for examination of NAP in biological mediums, bulk sample and in various dosage formulation. Spectrometric methods for NAP alone and in mixture are given in Table 08 which includes parameters like λ max, solvent, matrix etc.
2014
Purpose: To determine naproxen levels in human plasma using a new liquid chromatography-Mass spectroscopy/Mass spectroscopy (LC-MS/MS) method that involves a simple and single step extraction procedure using low-cost reagents. Method: A novel liquid chromatography‐tandem mass spectrometry method for the quantitative determination of naproxen in human K2-EDTA plasma in negative ion mode was employed and validated using zidovudine as internal standard (IS). Sample preparation was accomplished by liquidliquid extraction technique. The eluted samples were chromatographed on Zorbax Eclipse XDB phenyl 4.6 ◊ 75 mm, 3.5 µm column (Agilent Technologies) using a mobile phase consisting of acetonitrile: 20 mM ammonium acetate (90:10 v/v).The injection volume was 15 µL and the total run time was 3.0 min. The method was validated for all parameters for naproxen. Results: The method showed selectivity and linearity over a concentration range of 500.1 ng/mL to 100028.5 ng/mL The validation data in...
Bangladesh Pharmaceutical Journal, 2015
A simple, sensitive and precise reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of naproxen in pharmaceutical dosage forms. The method was developed using the mobile phase comprising of dibasic sodium phosphate buffer (Na 2 HPO 4 ) at pH 7.80 (adjusted by sodium hydroxide) and acetonitrile in the ratio of 70:30 (v/v) over C-18 column (250 x 4.6 mm, 5µm, Phenomenex Inc.) at ambient temperature. The flow rate was at 0.7 ml/min and the column washing was monitored by UV detector at 225 nm. The retention time of naproxen was 4.8 ± 0.1 min. The recovery was found to be >97% which is demonstrative of accuracy of the protocol. Inter-day and intra-day precision of the newly developed method were less than the maximum allowable limit (RSD% ≤ 2.0) according to ICH, USP and FDA guidelines. The method showed linear response with correlation coefficient (r 2 ) value of 0.9991. Therefore, the method was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for routine analysis of naproxen in pharmaceutical formulations.
Spectrophotometric Determination of Naproxen in Pure and Pharmaceutical Preparations
Analytical Letters, 1999
A highly sensitive, accurate and simple spectrophotometric method was established for determination of naproxen (NAP). The method involved ion-pair complex formation between naproxen and bromophenol blue (BPB). The colored product was measured at 432 nm. The reaction conditions were optimized. The absorbance was found to increase linearly with increase in concentration of NAP which was corroborated by correlation coefficient value. Beer's law was obeyed in the concentration range of 1-110 µg mL-1 with molar absorptivity of 9.756×10 3 L mol-1 cm-1. The limits of detection (LOD) and quantitation (LOQ) for the proposed method are 0.292 and 0.973 µg mL-1 , respectively. Recovery of the method was carried out by standard addition method. Recovery studies and statistical data proved the accuracy, reproducibility and the precision of the proposed method. The common excipients did not interfere in this analysis. Hence the method is useful for routine estimation of naproxen in pharmaceutical formulation and human serum samples.
Am. J. PharmaTech Res., 2017
A rapid, simple, selective, and specific reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for estimation of Naproxen and Sumatriptan from tablet using spiked human plasma. The chromatographic separation was performed on Phenomenex Luna C18 column (5μm, 25cmx4.6mm id) with a mobile phase comprised of Acetonitrile: Methanol: phosphate buffer pH 6 (50:10:40 v/v), at a flow rate of 1.0ml/min. The calibration curve was linear in the range of 1-3 µg/ml. The developed method was found to accurate and sensitive. Results of recovery studies prove the extraction efficiency. Stability data indicated that Sumatriptan and Naproxen was stable in plasma after three freeze thaw cycles and upon storage at −20°C for 30 days.
Journal of Natural Sciences Research, 2015
A New RP-HPLC technique was development and validation of effective and economical tool for quantitative estimation of Naproxen in dosage forms rapid, reproducible and selective reverse phase HPLC method has been developed for the estimation of Naproxen in dosage form.It was resolved by using a mobile phase of Potassium dihydrogen phosphate: methanol in the ratio 30:70 v/v at a flow rate of 0.8 ml/min. on HPLC system using UV-Visible detector at the wavelength of 287 nm. The column used was C18 (4.6 x 150mm, 3 mm, Make: Zorbax) .The linearity range was found to be 10-50 µg/ml. The proposed new method is found to be economic, sensitive, precise, rapid and reproducible.
Stereoselective determination of S-naproxen in tablets by capillary electrophoresis
Journal of Pharmaceutical and Biomedical Analysis, 1998
A capillary electrophoresis (CE) method was developed for the stereoselective determination of the non-steroidal anti-inflammatory drug (NSAID), S-naproxen, in tablets. Several i-cyclodextrin derivatives (CDs) were tested as chiral selectors, including sulfobutyl-i-CD (SBCD), carboxymethyl-i-CD (CMCD), dimethyl-i-CD (DMCD) and trimethyl-i-CD (TMCD), in a phosphoric acid/triethanolamine pH 3 buffer. Under these conditions, the analyte was mainly present in an uncharged form and therefore, the use a neutral CD (DMCD or TMCD) alone could not lead to enantiomeric separation. On the contrary, by addition of a charged CD (SBCD or CMCD) to the running buffer, giving the analyte enantiomers an adequate mobility, chiral resolution could be achieved, although the resolution values obtained in this case were not quite satisfactory (RsB 1.5). Dual systems, based on the use of mixtures of charged and neutral CDs, were then investigated. The SBCD/TMCD system was found to be particularly well suited to the enantioseparation of naproxen and after optimisation of the concentrations of both CDs, a resolution value of 5.4 could be obtained. The method was validated for the determination of R-naproxen (enantiomeric impurity) in the 0.1-2% range, using the racemic mixture of the analyte. A second validation was performed in the 50 -150% range for the quantitation of S-naproxen. In both cases, good results with respect to linearity, precision and accuracy were obtained.
Bioequivalence Study with Two Naproxen Sodium Tablet Formulations in Healthy Subjects
Journal of Bioequivalence & Bioavailability, 2009
The purpose of this study was to find out whether the bioavailability of a 550 mg naproxen sodium (CAS 22204-53- 1 ) tablet (Sunprox, test) produced by Sunward Pharmaceutical Sdn Bhd was equivalent to that produced by the innovator. The pharmacokinetic parameters assessed in this study were area under the plasma concentration-time curve from time zero to 72 hours (AUC t ), area under the plasma concentration-time curve from time zero to infinity (AUC inf ), the peak plasma concentration of the drug (C max ), time needed to achieve the peak plasma concentration (t max ), and the elimination half life (t 1/2 ). This was a randomized, single blind, two-period, cross-over study which included 26 healthy adult male and female subjects under fasting conditions. In each of the two study periods (separated by a washout of one week) single dose of test or reference drug was administered. Blood samples were taken up to 72 h post dose, the plasma was separated and the concentration of naproxen...
Human pharmacology of naproxen sodium
The Journal of pharmacology and experimental therapeutics, 2007
We compared the variability in degree and recovery from steady-state inhibition of cyclooxygenase (COX)-1 and COX-2 ex vivo and in vivo and platelet aggregation by naproxen sodium at 220 versus 440 mg b.i.d. and low-dose aspirin in healthy subjects. Six healthy subjects received consecutively naproxen sodium (220 and 440 mg b.i.d.) and aspirin (100 mg daily) for 6 days, separated by washout periods of 2 weeks. COX-1 and COX-2 inhibition was determined using ex vivo and in vivo indices of enzymatic activity: 1) the measurement of serum thromboxane (TX)B(2) levels and whole-blood lipopolysaccharide-stimulated prostaglandin (PG)E(2) levels, markers of COX-1 in platelets and COX-2 in monocytes, respectively; 2) the measurement of urinary 11-dehydro-TXB(2) and 2,3-dinor-6-keto-PGF(1alpha) levels, markers of systemic TXA(2) biosynthesis (mostly COX-1-derived) and prostacyclin biosynthesis (mostly COX-2-derived), respectively. Arachidonic acid (AA)-induced platelet aggregation was also stu...