A green approach for the quantification of daptomycin in pharmaceutical formulation by UV spectrophotometry

Abstract

Daptomycin is the first approved drug from a new class of antimicrobials, the cyclic lipopeptides, and is a very important antimicrobial agent in current clinical practice. Currently, there are no "green" analytical methods described in the literature to analyze the typical pharmaceutical dosage form of daptomycin. Thus, the aim of this work was to validate an environment-friendly spectrophotometric method in the UV region, for the analysis of daptomycin as a lyophilized powder. Water was used as diluent and the analyses were carried out on a spectrophotometer at 221 nm. The method met all validation requirements of the ICH guidelines, over a concentration range of 6-21 µg mL -1 . A Student's t-test demonstrated that the proposed method was comparable to an HPLC method previously validated. Thus, the validated spectrophotometric method could quantify daptomycin in a powder form for injectable solutions, while being an economical, rapid, and "green" alternative for routine analysis in quality control.Uniterms: Antimicrobials/quality control. Daptomycin/determination. Spectrophotometry/UV region/ quantitative analysis. Spectrophotometry/green analytical method.A daptomicina é o primeiro membro aprovado de uma nova classe de antimicrobianos, os lipopeptídeos cíclicos, e é muito importante para a prática clínica atualmente. Não existem métodos analíticos "verdes" descritos na literatura para a análise da daptomicina na forma farmacêutica. Desta forma, o objetivo deste trabalho foi a validação de método espectrofotométrico na região do UV ambientalmente favorável para análise da daptomicina em pó liofilizado. A água foi escolhida como diluente e as análises foram realizadas em 221 nm. O método atendeu a todas as exigências de validação dos guias do ICH, na faixa de 6-21 µg mL -1 . Teste t de Student mostrou que o método proposto é intercambiável com método de HPLC previamente validado. Assim, o método espectrofotométrico validado é capaz de quantificar a daptomicina em pó para solução injetável e é uma opção econômica, rápida e "verde" para análises de rotina do controle de qualidade deste fármaco.Unitermos: Antimicrobianos/controle de qualidade. Daptomicina/determinação. Espectrofotometria/ região do UV/análise quantitativa. Espectrofotometria/método analítico verde. INTRODUCTIONIt is widely known that microbial resistance is a major problem worldwide. Many bacteria have developed resistance to a large number of antimicrobial agents available on the market; these bacteria are considered challenges for medicine. Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE) are two examples of antimicrobialresistant microorganisms (Silveira et al., 2006;Wright, 2011). Compounding the problem of antimicrobial resistance, there are few new antimicrobial agents emerging in the market (Wright, 2011).One recent development in antimicrobial treatment is the introduction of daptomycin into the marketplace (Figure 1). This is the first antimicrobial agent from the cyclic lipopeptide class appro...

Besifloxacin: A Critical Review of Its Characteristics, Properties, and Analytical Methods

“…[62][63][64][65] However, it is a non-selective method and is not suitable for the detection of degradation products and impurities. [66] Spectrophotometric methods are also found in literature for other fluoroquinolones, such as ciprofloxacin, [67] norfloxacin, [68,69] orbifloxacin, [70] lomefloxacin, [71] gatifloxacin, [72] and sparfloxacin. [73,74] Costa et al (2014) developed and validated a microbiological agar diffusion method for the potency analysis of besifloxacin in ophthalmic suspension.…”

Development of a Fast, Low‐Cost, Conservative and Ecological Method for Quantifying Gallic Acid in Polymeric Formulations by FTIR Spectroscopy in Solution

“…Chromatographic methods, such as thin‐layer chromatography (TLC), high‐performance thin‐layer chromatography (HPTLC), TLC densitometric analysis, gas chromatography, high‐performance liquid chromatography (HPLC) and ultra‐performance liquid chromatography (UPLC), for their great power and resolution, are extensively used for the qualitative identification and quantification of GA in different matrices. On the other hand, for good results, these methods require a correct selection of both stationary and mobile phases and retention times, which depend on the gradient system used in the analysis, can be very different.…”

Cyclic Lipopeptide Antibiotic Daptomycin Electrochemical Oxidation at a Glassy Carbon Electrode

“…The CVs showed two oxidation peaks, the first a well‐defined, oxidation peak P1, at E pa1 =+0.85 V for pH 4.0, Figure , and at E pa1 = + 0.74 V for pH 7.0, and the second a smaller oxidation peak P2, at E pa2 =+ 0.85 V for pH 4.0, and at E pa2 = + 1.05 V for pH 7.0. Reversing the scan direction, no reduction peak appeared for either pH, indicating that the oxidation process is irreversible . Recording successive scans in the same solution, without cleaning the electrode surface, both peak currents decreased, due to the adsorption of DPT and/or its oxidation products at the GCE surface, Figure 1.…”

“…The scan rate effect on the oxidation process of DPT oxidation peak P1 was investigated recording CVs, in 25 μM DPT, in 0.1 M phosphate buffer pH 7.0, at scan rates between 5–50 mVs −1 , always using a clean GCE. The oxidation peak P1 current, I pa (A)=2.69 × 10 5 n (α c n ’) 1/2 A [R] ∞ D O 1/2 ν 1/2 , increased linearly with ν 1/2 , indicating that the oxidation process was diffusion‐limited and the value of the DPT diffusion coefficient in 0.1 M phosphate buffer pH 7.0, was calculated as D DPT = 2.32 × 10 −5 cm 2 s −1 . The GCE electroactive area, A =4.17 × 10 −3 cm 2 , was determined using 1.0 mM hexacyanoferrate(II) in phosphate buffer solution ( D O = 7.35 × 10 −6 cm 2 s −1 ).…”

“…Most DPT quantification and detection studies are directed towards biological fluid analysis, using mainly chromatographic methods with different detectors, such as high performance liquid chromatography with ultraviolet , mass , and tandem mass spectrometry , liquid chromatography with ultraviolet , mass and tandem mass spectrometry , , ultra and ultra‐high performance liquid chromatography with ultraviolet , tandem mass spectrometry and photodiode array . Some other techniques have also been investigated , .…”