Simple analysis of amoxycillin in plasma by high performance liquid chromatography with internal standardization and ultraviolet detection

Charles, Bruce G.; Chulavatnatol, Suvatna

doi:10.1002/bmc.1130070407

Cited by 24 publications

(14 citation statements)

References 16 publications

(9 reference statements)

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“…A large number of plasma samples (n ϭ 1,152) collected from 48 closely monitored, healthy volunteers in two bioequivalence studies allowed the development and subsequent validation of LSS models by using several different procedures. The results show that the AUC 0-ϱ of amoxicillin, following administration of single oral doses (500 ) for amoxicillin in 11 previously published studies (1,3,7,10,13,14,(17)(18)(19)(20)26), and the corresponding AUC 0-ϱ derived from the three-point LSS model developed for the reference capsule formulation in the present study (Table 3, (Table 2). The statistical principle of parsimony advises in favor of models with fewer parameters; thus, we settled for three-sample regressions for independent estimation of amoxicillin's AUC 0-ϱ .…”

Section: Discussionsupporting

confidence: 58%

“…The robustness of the three-point LSS regression equation derived from the capsule formulation data set as a predictor of the plasma amoxicillin AUC 0-ϱ was confirmed when tested on data from 11 published studies (1,3,7,10,13,14,(17)(18)(19)(20)26), encompassing a large range of amoxicillin single doses (250 to 1,000 mg) and AUC 0-ϱ 's (9 to 55 g ⅐ h ⅐ ml Ϫ1 ). This result not only validates our proposed three-point LSS model but also extends its applicability to a variety of experimental conditions, both clinical and analytical, which prevailed in the 11 studies examined.…”

Section: Discussionmentioning

confidence: 83%

“…As a third test of the validity of the LSS models developed for estimating amoxicillin's AUC 0-ϱ , the most informative three-point LSS equation derived for the training data set (reference capsule formulation) was used to estimate the AUC 0-ϱ of subjects enrolled in 11 previously published studies after administration of single oral doses (250 to 1,000 mg) of various amoxicillin formulations (1,3,7,10,13,14,(17)(18)(19)(20)26). Scanned plots of the published AUCs were used to obtain the data points employed for the LSS-derived AUC 0-ϱ 's and to obtain the best estimated AUC 0-ϱ 's by means of the trapezoidal method.…”

Section: Clinical Protocolmentioning

confidence: 99%

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Development and Validation of Limited-Sampling Strategies for Predicting Amoxicillin Pharmacokinetic and Pharmacodynamic Parameters

Suarez‐Kurtz

Ribeiro

Vicente

et al. 2001

Antimicrob Agents Chemother

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Amoxicillin plasma concentrations (n ‫؍‬ 1,152) obtained from 48 healthy subjects in two bioequivalence studies were used to develop limited-sampling strategy (LSS) models for estimating the area under the concentration-time curve (AUC), the maximum concentration of drug in plasma (C max ), and the time interval of concentration above MIC susceptibility breakpoints in plasma (T>MIC). Each subject received 500-mg amoxicillin, as reference and test capsules or suspensions, and plasma concentrations were measured by a validated microbiological assay. Linear regression analysis and a "jack-knife" procedure revealed that threepoint LSS models accurately estimated ( Amoxicillin, a well-known amino-substituted penicillin, enjoys widespread clinical use, not only because of its broad antibacterial spectrum but also because of its high oral bioavailability (Ͼ90%), which makes it relatively unaffected by food or by other concomitantly administered drugs. The pharmacokinetics of amoxicillin has been extensively investigated (reviewed in reference 15) , and the compounded data indicate that an oral dose of 500 mg produces peak concentrations in plasma of about 10 g/ml within 1 to 1.5 h, reaches adequate therapeutic concentrations in pleural, synovial, and ocular fluids, and accumulates in the amniotic fluid, but penetrates poorly into the central nervous system unless inflammation is present. Excretion of amoxicillin is predominantly renal, and Ͼ80% of an intravenous dose is recoverable in the urine, leading to very high urinary concentrations. The drug's terminal half-life (t 1/2 ) of elimination is 1 to 1.5 h.Amoxicillin is the single active principle of at least 26 formulations marketed in Brazil (4), the vast majority of which were not subjected to bioavailability studies prior to registration. Recently, however, the Brazilian agency for drug control, Agência Nacional da Vigilância Sanitária, decreed that bioequivalence studies are mandatory for the registration of generic products and issued guidelines for such studies, which can be performed only at accredited centers (2). This prompted an immediate increase in the demand for such studies, two of which, carried out by our group, assessed the bioequivalence of generic formulations of amoxicillin. The concentration-inplasma data points (n ϭ 1,152 samples) obtained from 48 subjects enrolled in these studies were then used to develop and validate limited-sampling strategy (LSS) models (21, 22) to estimate the major bioequivalence metrics, namely, the area under the concentration-time curve (AUC) and the maximum concentration of drug in plasma (C max ) of amoxicillin. In addition, a similar linear regression approach was carried out in order to develop an LSS for predicting the time interval that amoxicillin concentrations in plasma exceed MIC susceptibility breakpoints (TϾMIC), chosen as a dynamically linked variable. The results indicate that three-point LSS models, based on the same sampling times, provide accurate estimates of both AUC from 0 h to infinity (AUC 0-ϱ ) a...

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Section: Discussionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 83%

Section: Clinical Protocolmentioning

confidence: 99%

See 1 more Smart Citation

Development and Validation of Limited-Sampling Strategies for Predicting Amoxicillin Pharmacokinetic and Pharmacodynamic Parameters

Suarez‐Kurtz

Ribeiro

Vicente

et al. 2001

Antimicrob Agents Chemother

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“…6,7) This method is as precise as HPLC assay 10,11) ; it has been widely used to determine amoxicillin concentration. 18,19) The tissue wet weight values revealed differences among groups. The reduction in the tissue wet weight verified in group 4 might be due to the high sodium diclofenac anti-inflammatory activity, 12) and inhibition of both leukocyte migration 20) and superoxide production.…”

Section: Discussionmentioning

confidence: 99%

Effect of Sodium Diclofenac on Serum and Tissue Concentration of Amoxicillin and on Staphylococcal Infection

Groppo

Simões

Ramacciato

et al. 2004

Biological & Pharmaceutical Bulletin

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Amoxicillin is a widely prescribed aminopenicillin, primarily for oral use.1) Ninety percent of the administered dose is absorbed without molecular modifications.2) It provides human serum concentration ranging from 7.6 mg/ml to 10.8 mg/ml when 500 mg/p.o. is used 3,4) ; 15.1 mg/ml when 15.4 mg/kg/p.o. is used, 1) and 14.5 mg/ml when 40 mg/kg/p.o. is used.5) The serum concentrations in rats were 28 mg/ml and 13 mg/ml when amoxicillin doses of 40 mg/kg/p.o. and 7.0 mg/kg/p.o. were administered, respectively. 6,7)

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“…Charles ve Chulavatnatol [2] tarafından yapılan çalışmada, amoksisilin plazmada HPLC yöntemi ile UV dedektör kullanılarak miktar tayininin yapılması amaçlanmıştır. 229 nm dalga boyunda çalışılmıştır.…”

Section: Introductionunclassified

Deneysel Tasarim Metodu Kullanilarak Yüksek Performansli Sivi Kromatografi̇si̇ İle Amoksi̇si̇li̇n Tayi̇ni̇

Keyf¹

2017

Ömer Halisdemir Üniversitesi Mühendislik Bilimleri Dergisi

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ÖZETYaygın bir antibiyotik olan amoksisilinin analizinde yüksek performanslı sıvı kromatografisi (HPLC) kullanılmaktadır. İlaç endüstrisinde gerçekleştirilen analizlerde zaman ve maliyet önemlidir. Bu nedenle bu çalışmada HPLC ile amoksisilin analizinde optimizasyon için kemometrik yöntemler kullanılmıştır. Mobil fazın metanol oranı, pH'sı ve akış hızı faktör olarak, alıkonma zamanı, pik alanı ve pik yüksekliği cevap yüzeyi olarak belirlenmiştir. Faktörler ve cevap yüzeyleri arasındaki bağıntı Design Expert 7.0.0. programı kullanılarak elde edilmiştir. Optimizasyon, alıkonma zamanı 5-6 dakika tutularak gerçekleştirilmiştir. Deneysel optimizasyon değerleri Merkezi Bileşik Tasarım Yöntemiyle hesaplanan değerlerle karşılaştırıldığında, pH için %99,6, akış hızı için %95, metanol yüzdesi için %98 doğruluk tespit edilmiştir. Phenomenex C18 100A (250×4,00 mm, 5 µm) kolonunun kullanıldığı yöntemde optimum koşullar %15 metanol, pH 8,5 ve akış hızı 0,8 mL/dk şeklinde belirlenmiş, yöntemin belirleme sınırı (LOD, alan için) 0,0134 mg/L ve tayin sınırı (LOQ, alan için) 0,0452 mg/L olarak saptanmıştır.Anahtar kelimeler: Antibiyotik, amoksisilin, HPLC, kemometri DETERMINATION OF AMOXYSILINE BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY USING EXPERIMENTAL DESIGN METHOD ABSTRACTHigh performance liquid chromatography (HPLC) is used for analysis of amoxicillin which is an antibiotic widely used. Time and cost of analysis performed in the pharmaceutical industry are important. Therefore, in this study, chemometric methods were used to optimize amoxysiline analysis by HPLC. The percentage of methanol in the mobile phase, pH and flow rate were used as a factor, the retention time, peak area and peak height were defined as the response surface. Correlation between these factors and the response surface was obtained using Design Expert 7.0.0. program. Optimization was performed by keeping retention time around 5-6 min. The experimental optimization variables values and calculated optimization variables values by using Central Composite Design Method were compared, and the accuracy of 99.6% for pH, 95% for flow rate and 98% for methanol percentage was determined. Optimum conditions for HPLC method with Phenomenex C18 100A (250 x 4.00 mm, 5 μm) column were 15% methanol, 8.5 pH and 0.8 mL/min flow rate, and the analytical performance of the method was as follows: limit of detection (LOD, for area) 0.0134 mg/L and limit of quantification (LOQ, for area) 0.0452 mg/L.

show abstract

Simple analysis of amoxycillin in plasma by high performance liquid chromatography with internal standardization and ultraviolet detection

Cited by 24 publications

References 16 publications

Development and Validation of Limited-Sampling Strategies for Predicting Amoxicillin Pharmacokinetic and Pharmacodynamic Parameters

Development and Validation of Limited-Sampling Strategies for Predicting Amoxicillin Pharmacokinetic and Pharmacodynamic Parameters

Effect of Sodium Diclofenac on Serum and Tissue Concentration of Amoxicillin and on Staphylococcal Infection

Deneysel Tasarim Metodu Kullanilarak Yüksek Performansli Sivi Kromatografi̇si̇ İle Amoksi̇si̇li̇n Tayi̇ni̇

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