Determination of naproxen in human plasma by GC–MS (original) (raw)
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Bioanalytical Validated LC-MS Method for Determination of Naproxen in Human Plasma
Naproxen is an anti-inflammatory drug belongs to the category of analgesics and antipyretics. Naproxen has the ability to bind and inhibit the synthesis of prostaglandins and produces anti-inflammatory effect. Naproxen also inhibits COX-II which is involved in the inflammation. Bioanalytical method for naproxen has been developed using human plasma. Standard stock solution of naproxen was prepared using methanol. Zidovudine was used as internal standard. The linearity of the proposed method was developed in the range between 100 and 10000 ng/ml. The slope of the curve was found to be 111.46 and intercept was 6395.2 and correlation coefficient was 0.999. The proposed method was evaluated with validation parameters like accuracy, precision and stability. The developed method is suitable for pharmacokinetic studies.
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.
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.
Determination of Ibuprofen in Human Plasma and Urine by Gas Chromatography/Mass Spectrometry
Journal of AOAC INTERNATIONAL, 2014
This paper describes a GC/MS method for the determination of ibuprofen in human plasma and urine. Ibuprofen and internal standard naproxen were extractedfrom plasma and urine by using a liquid–liquid extraction method. Derivatization was carried outusing N-methyl-N-(trimethylsilyl) trifluoroacetamide. Calibration curves were linear over the concentration range of 0.05–5.0 and 0.1–10.0 μg/mL for plasma and urine, respectively. Intraday and interday precision (RSD) values for ibuprofen in plasma and urine were less than 6.31%, and accuracy (relative error) was better than 12.00%. The mean recovery of ibuprofen was 89.53% for plasma and 93.73% for urine. TheLOD was 0.015 and 0.03 μg/mL and the LOQ was 0.05 and 0.1 μg/mL for plasma and urine, respectively. The method was successfully applied to blood samples from three healthy male volunteers who had been given an oral tablet of 600 mg ibuprofen.
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.
Determination of Ibuprofen in human plasma with minimal sample pretreatment
Int J Pharm Sci Res, 2010
A simple, sensitive and selective high performance liquid chromatography (HPLC) method with ultraviolet detection (220 nm) was developed and validated for the quantification of Ibuprofen and in human plasma. Following rapid sample preparation, the analytes and internal standard (Diclofenac sodium) were separated using an isocratic mobile phase on a reverse phase C8 column. The lower limit of quantification was 1µg/mL for Ibuprofen. A linear dynamic range of 1µg/mL to 100µg/mL for Ibuprofen was established. This HPLC method was validated with between and within-batch precision of 1.2-4.7% and 1.8-4.8 %, respectively. The between and within batch accuracy was 99.4-104.2% and 99.7-104.1%, respectively. Frequently co-administered drugs did not interfere with the described methodology. Stability of Ibuprofen in plasma was >90%, with no evidence of degradation during sample processing (autosampler) and 60 days storage in a freezer. This validated method is sensitive and simple with between-batch precision of < 5 % and was used in pharmacokinetic studies.
Spectrofluorometric determination of naproxen in tablets
Journal of Pharmaceutical and Biomedical Analysis, 2002
A rapid, selective, sensitive and simple fluorescence method was developed for the direct determination of naproxen in tablets. The tablets were triturated, dissolved in either NH 3 or NaOH solution, sonicated, filtered and then direct fluorescence emission was read at 353 nm (exciting at 271 nm). In order to validate the method the results were compared with those obtained by the USP XXIV NF 19 Pharmacopeia reference method (high performance liquid chromatography). The slope, intercept and variances which are associated with the regression coefficient calculated with bivariate least square (BLS) regression indicate that both methods are statistically comparable. The recoveries were excellent, except in tablets containing the antibiotic tetracycline. In this latter case a correction procedure is necessary.
WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
A simple, precise, and rapid reversed-phase high performance liquid chromatography (HPLC) method for the determination of ibuprofen (IBU) in human plasma using gemfibrozil as an internal standard (IS) was developed and validated. Plasma samples containing ibuprofen were spiked with the IS, precipitated with methanol, and centrifuged. The compounds of interest were efficiently separated on Symmetry Shield RP18 column maintained at a temperature of 40C, and detected with multi-wave length fluorescence detector (excitation/emission wavelength 230/ 275 nm). The mobile phase consisted of 0.01M dibasic ammonium phosphate (pH adjusted to 5.5 with phosphoric acid) and acetonitrile (45:55, v:v), and was delivered at a flow rate of 1.5 ml/min. The relationship between ibuprofen concentration in plasma and peak area ratio of ibuprofen / IS was linear (R2 0.9997) in the range of 0.25 -60 μg/ml, the intraand inter-day coefficient of variations (CV) were ≤ 3.8% and ≤ 2.9%, respectively. Extraction recoveries of ibuprofen and the IS were > 90%, whereas the accuracy (relative recovery) of ibuprofen measurement was 98% to 107% using quality control samples and 92% to 105% as determined by back calculation from peak area ratios of the calibration curves. The method was used to assess the stability of ibuprofen in human plasma under various conditions in the clinical laboratory. Further, it was successfully employed to measure ibuprofen levels in samples obtained normal volunteer. W WO OR RL LD D J JO OU UR RN NA AL L O OF F P PH HA AR RM MA AC CY Y A AN ND D P PH HA AR RM MA AC CE EU UT TI IC CA AL L S SC CI IE EN NC CE ES S S SJ JI IF F I Im mp pa ac ct t F Fa ac ct to or r 2 2. .7 78 86 6
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.