A New Ecological HPLC Method for Determination of Vancomycin Dosage form

Abstract

Aims: A New Ecological Hplc Method For Determination Of Vancomycin Dosage Form. Background: Vancomycin is an important antimicrobial. There are many methods using HPLC in literature, but it was not found any that follows the green analytical chemistry principles. Objective: So, a green analytical method to quantify vancomycin in lyophilized powder for injectable solution by HPLC was developed. Method: It uses less quantity of toxic solvents, minimizing the costs and optimizing the time of analysis. Water + 0.1% acetic acid and ethanol (85:15, v/v), 0.5 mL min-1, C18 column (15 cm) at 280 nm were used. Result: The method was linear in the range of 40 to 140 µg mL-1, with a correlation coefficient of 0.9998. It was selective when subjected to acid 0.1M, basic 0.01M, oxidative 0.3%, UV light and neutral degradation in a bath of 60 ºC for 8 hours. The precision of the method was proved at intraday (RSD 1.08%), interday (RSD 0.47%) and intermediate levels (RSD 2.35%). It was accurate with mean recovery of 100.19% and robust when changes were performed in seven parameters of the method and analyzed by the Youden and Steiner test. Conclusion: The method can be applied to routine quality control of vancomycin lyophilized powder for injectable solution as an ecological and sustainable alternative that contemplates the green analytical chemistry and the current pharmaceutical analyzes.

A new and ecological miniaturized method by spectrophotometry for quantification of vancomycin in dosage form

“…The vancomycin solution was submitted to acidic, alkaline, oxidative, aqueous and photolytic media and in all conditions the band of maximum absorbance of vancomycin was smaller when compared to the spectra obtained in time 0 (Table 2), showing the susceptibility of the method and its capacity to indicate stability. In a study by HPLC (31), vancomycin in lyophilized powder was degraded under the same forced conditions as this work and the results (after the same periods of time) also showed the susceptibility of the method and its ability to indicate the stability of the sample. After all, forced degradation studies challenge the method, which must be able to reveal the true situation of the drug.…”

“…After all, forced degradation studies challenge the method, which must be able to reveal the true situation of the drug. In this context, the spectrum obtained in the oxidative condition showed relevant tracing distortion, which may be due to the possible degradation of the drug and the appearance of degradation products, as revealed in the study by HPLC (31), or to the interference of the preservative present in the solution of H2O2, also seen in other studies of forced degradation analyzed by UV (32)(33). And, even in this context, the unchanged tracings of the other degradations may be suggestive of a small instability of the molecule (results shown in Table 2), which corroborates the results by HPLC (31).…”

Improving the reproducibility of size distribution of protein crystals produced in continuous slug flow crystallizer operated at short residence time

“…3.1)The purities of the O and SAN crystals were determined by dissolving 15 mg lyophilized crystals in 100 mL acetate buffer (pH 5.6). Van concentration in the buffer was subsequently determined by high performance liquid chromatography (HPLC) (1260 Infinity II (Agilent Technologies, Singapore) using ZORBAX Eclipse Plus C18 column (250 × 4.6 mm, 5-μm particle size) at detection wavelength of 280 nm[287]. 85:15 (v/v) mixture of 0.1% (w/v) aqueous acetic acid solution and ethanol was used as the mobile phase at flow rate of 0.5 mL/min, resulting in Van retention time of approximately 4.5 min.3.2.2.4 Characterizations of Van crystals from batch crystallizationThe crystal size distributions (CSD) of the O and SAN crystals were characterized by the Span defined in Eq.…”