Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures

Atici, Esen Bellur; Yazar, Yücel; Ağtaş, Çağan; Rıdvanoğlu, Nurten; Karliga, Bekir

doi:10.1016/j.jpba.2016.12.032

Cited by 19 publications

(6 citation statements)

References 13 publications

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“…40 This should cause a shift in the elution peaks and a decrease in the peak intensities in HPLC. 41,42 Thus, we examined the stability of three hydrogel formulations of the same metolose and amoxicillin content prepared under various pH (i.e., pHs 4, 5, and 6), taking the commercially available amoxicillin syrup as a control. All of the formulations were stored in glass vials at room temperature and in darkness for a period of 3 months.…”

Section: Resultsmentioning

confidence: 99%

Cold Chain-Free Storable Hydrogel for Infant-Friendly Oral Delivery of Amoxicillin for the Treatment of Pneumococcal Pneumonia

Cui

et al. 2017

ACS Appl. Mater. Interfaces

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Pneumonia is the major cause of death in children under five, particularly in developing countries. Antibiotics such as amoxicillin greatly help in mitigating this problem. However, there is a lack of an infant/toddler-friendly formulation for countries with limited clean water orr electricity. Here, we report the development of a shear-thinning hydrogel system for the oral delivery of amoxicillin to infant/toddler patients, without the need of clean water and refrigeration. The hydrogel formulation consists of metolose (hydroxypropyl methylcellulose) and amoxicillin. It preserves the structural integrity of antibiotics and their antibacterial activity over 12 weeks at room temperature. Pharmacokinetic profiling of mice reveals that the hydrogel formulation increases the bioavailability of drugs by ∼18% compared to that with aqueous amoxicillin formulation. More importantly, oral gavage of this formulation in a mouse model of secondary pneumococcal pneumonia significantly ameliorates inflammatory infiltration and tissue damage in lungs, with a 10-fold reduction in bacterial counts compared to those in untreated ones. Given the remarkable antibacterial efficacy as well as the use of FDA-regulated ingredients (metolose and amoxicillin), the hydrogel formulation holds great promise for rapid clinical translation.

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Section: Resultsmentioning

confidence: 99%

Cold Chain-Free Storable Hydrogel for Infant-Friendly Oral Delivery of Amoxicillin for the Treatment of Pneumococcal Pneumonia

Cui

et al. 2017

ACS Appl. Mater. Interfaces

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“…Another factor to be considered was the method used to determine the amoxicillin concentration by means of a standard curve in accordance with the halo measurements regarding S. aureus inhibition. The microbiological method is effective in measuring amoxicillin concentrations in body and tissues fluids [6]; however, other techniques have been developed to assess the amount of antimicrobial agents in lowvolume samples more accurately, including mercurimetric, high-performance liquid chromatography, iodometry, optical methods and ultraviolet spectrophotometry [13][14][15][16][17][18]. Nevertheless, these methods are unable to assess whether or not the antibiotic is active.…”

Section: Discussionmentioning

confidence: 99%

Influence of ibuprofen-arginine on the concentration of amoxicillin in the plasma and tissues of rats with induced periapical lesion

Mackeivicz

Castro

Rossi

et al. 2020

RGO, Rev. Gaúch. Odontol.

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Objective The aim of this study was to evaluate the influence of ibuprofen-arginine on the concentration of amoxycillin in the plasma and periapical tissues of rats with induced apical periodontitis. Methods Twenty-eight Wistar rats were divided into the following four groups: PL: placebo (saline); AM: amoxycillin (100 mg/kg); IB: ibuprofen-arginine (100 mg/kg); and AM+IB: amoxycillin (100 mg/kg) + ibuprofen-arginine (100 mg/kg). The animals were submitted to pulp exposure in the first lower left molar, which remained open for fifteen days; this was then closed with composite resin and remained for a further seven days. The treatments were performed using a single dose of the medication (gavage) one hour before taking the samples. Two mL of blood was collected from the aorta to obtain the blood plasma and the periapical tissue samples, which were homogenized to obtain the supernatant. The samples (plasma and the supernatant periapical tissue) were used to obtain the antibiogram for the analysis of the levels of amoxycillin in the plasma and periapical tissues. Results The amoxycillin concentration was higher in the AM group compared to the other groups (p < 0.05, ANOVA with Tukey’s test). Ibuprofen-arginine interfered with plasma concentration of amoxycillin; however, the AM+IB group had a higher concentration of amoxycillin than the PL and IB groups (p < 0.05, ANOVA with Tukey’s test). The analysis of the supernatant from the periapical tissues showed no significant difference between the groups (p > 0.05, Kruskal-Wallis test). Conclusion Ibuprofenarginine can interfere with the plasma concentration of amoxycillin but this study failed to show the effect of ibuprofen-arginine on the concentration of amoxycillin in the periapical tissues .

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“…Development and validation of methods to determine the content of amoxicillin were carried out in five studies (12%), three were determined by LC method and two by UV/vis spectrophotometry method. The detection system of amoxicillin was performed at 215, 254 and 283 nm by LC [34] [35] [36]. In UV/vis spectrophotometry the content of amoxicillin were achieved at 397 nm and the method was based on the selective oxidation of amoxicillin with cerium (IV) or iron to give an intense yellow coloring product [29].…”

Section: Characteristics Of Methods and Active Ingredientsmentioning

confidence: 99%

Substandard/Falsification Antibacterial Agents: A Systematic Review of Liquid Chromatographic and Spectrophotometric Methods for Their Detection

Tshilumba¹,

Muindu²,

Kasongo³

et al. 2019

AJAC

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Falsified antibacterial agents continue to pose serious public health problems around the world. They are notably responsible for resistance emergence in the treatment of infectious diseases that can lead to death. The aim of this study was to summarize the literature on the methods developed and validated to detect poor quality antibacterial agents in order to assess the impact of these available methods in the fighting against Counterfeit/substandard medicines. Thus, studies published in the time from January 2000 to July 2017, were accessible via Google Scholar and Pubmed and allowed to analyze 41 papers. The majority (30) of developed and validated methods concerned LC methods, 9 regarded UV/V is spectrophotometry and two studies simultaneously developed both methods. Antibacterial agents belonging to beta-lactams group were the most concerned by the methods developed and validated (39%), followed by quinolones (18%) and macrolides (12%). Regarding active ingredients, amoxicillin (12%) was the most concerned by the development and validation methods. In spite of several available methods to detect substandard drugs, antibacterial agents for which methods were developed and validated were the most concerned by worldwide detected non-conformities. The fight against this scourge should not be only limited by their detection, but it also requires an effective involvement of different actors notably: health authorities, international organizations, pharmaceutical industries etc.

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Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures

Cited by 19 publications

References 13 publications

Cold Chain-Free Storable Hydrogel for Infant-Friendly Oral Delivery of Amoxicillin for the Treatment of Pneumococcal Pneumonia

Cold Chain-Free Storable Hydrogel for Infant-Friendly Oral Delivery of Amoxicillin for the Treatment of Pneumococcal Pneumonia

Influence of ibuprofen-arginine on the concentration of amoxicillin in the plasma and tissues of rats with induced periapical lesion

Substandard/Falsification Antibacterial Agents: A Systematic Review of Liquid Chromatographic and Spectrophotometric Methods for Their Detection

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