Development, Validation and Greenness Assessment of Three Simple Spectrophotometric Methods for Determination of Two Combined Broad-Spectrum Antibacterial Agents

Habeeb, Maha; morshedy, Samir; Daabees, Hoda G.; Elonsy, Sohila

doi:10.21608/ejchem.2023.178407.7263

Cited by 2 publications

(5 citation statements)

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“…A dark green colour in all pictograms and a score equals 1 are the descriptions of the ideal green method according to AGREE metric. In our comparison, the proposed CZE method showed the perfect greenness with a score of 0.94, followed by the 1 st reported spectrophotometric method [ 39 ] with a score of 0.89, and the 2nd reported spectrophotometric method [ 34 ] with a score of 0.78, and finally the HPLC method with a score of 0.71, as shown in Table 8 . The resultant greenness assessment proved the superiority of the capillary electrophoresis method.…”

Section: Resultsmentioning

confidence: 87%

“…According to the assay findings' % recovery, SD, and RSD% values, the accuracy and precision were satisfactory (Table 6 ). The results of the proposed method were statistically compared to those of the ratio difference spectrophotometric reference method [ 39 ] using the student t -test and variance ratio F -test. The statistical values did not exceed the theoretical ones of the 95% confidence level verifying the absence of any significant difference between the compared methods (Table 6 ).…”

Section: Resultsmentioning

confidence: 99%

“…Considering the previously reported methods based on what we know for the analysis of LIN and CEF, they showed only the use of spectrophotometric and HPLC chromatographic techniques. Therefore, the newly developed CZE method was compared in term of greenness with three of the previously reported methods: two spectrophotometric articles [ 34 , 39 ], one of them is a previous work of our research group [ 39 ], and a HPLC–UV [ 30 ] method as a representative example.…”

Section: Resultsmentioning

confidence: 99%

“…Literature review revealed that there is no previously published method for analyzing the selected combination using capillary electrophoresis. The presented method was compared in term of some points regarding the analytical performance with three of the previously reported methods, two spectrophotometric articles [ 34 , 39 ], and a HPLC–UV [ 30 ] reported method as a representative example. It was found that the introduced approach was of comparable or slightly lower sensitivity, as proved by the linearity range, LOD, and LOQ values that are presented in Additional file 1 : Table S2.…”

Section: Resultsmentioning

confidence: 99%

“…Gramocef L® is the marketed combined tablet formulation brand of LIN and CEF in the ratio of 600 mg: 200 mg respectively. Concurrent analysis of CEF and LIN in a fixed dose form was reported using HPLC methods [ 23 – 30 ], various spectrophotometric methods, including Vierodt’s method [ 31 – 35 ], the absorbance ratio method (Q analysis) [ 26 , 32 , 36 , 37 ], first order derivative spectrophotometry [ 38 ], zero crossing second derivative spectrophotometry [ 34 , 36 ], ratio derivative method [ 34 , 39 ], ratio difference method [ 39 ] and mean centering of ratio spectra [ 39 ]. To the extent that we are aware, this is the first electro-driven separation method utilizing capillary electrophoresis for concurrent analysis of the two cited drugs.…”

Section: Introductionmentioning

confidence: 99%

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Development, validation and greenness assessment of a new electro-driven separation method for simultaneous analysis of cefixime trihydrate and linezolid in their fixed dose combination

Habeeb,

Morshedy,

Daabees

et al. 2023

BMC Chemistry

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The establishment and validation of a straightforward, accurate, and eco-friendly capillary zone electrophoretic-diode array detection (CZE-DAD) procedure has been presented for concurrent measurement of two common antibiotics, namely, linezolid (LIN) and cefixime trihydrate (CEF), in their binary mixture or combined dosage form. The selected fused silica capillary has total and effective lengths equal to 58.5 cm and 50 cm, respectively, with a 50 µm internal diameter. Injections were performed utilizing 100 mM borate buffer at pH 10.2 as the background electrolyte (BGE) with a 15.0 s injection time. The finally utilized voltage was 30 kV. DAD was programmed to measure LIN at 250 nm and CEF at 285 nm. In less than 6 min, the two cited drugs were resolved at 2.51 and 5.47 min for LIN and CEF respectively. The introduced procedure had a linear response in the concentration range of 5–50 μg/mL for both analytes with correlation coefficients > 0.9999. Detection and quantification limits were 1.213 and 4.042 μg/mL, respectively, for LIN and 0.301 and 1.004 μg/mL, respectively, for CEF. Validation was conducted according to the International Council for Harmonization (ICH), concerning linearity, detection and quantitation limits, range, accuracy, precision, selectivity, and robustness. Precision was found acceptable due to the low relative standard deviation (RSD%) values that did not exceed 1.86% either for repeatability or for intermediate precision. Additionally, the adequately recovered concentrations and the low values of percentage relative error (Er%) provide evidence of the accuracy of the proposed method. On the other hand, the robustness of the introduced method was affirmed by the acceptable RSD% values that did not exceed 0.6% after deliberate changes in the following procedure parameters: buffer concentration, buffer pH, and wavelength. Finally, the ability of the presented method to quantify the two tested drugs in laboratory-prepared tablets was confirmed by the adequate recoveries (≥ 99%) utilizing the standard-addition procedure, along with the absence of any significant difference between the proposed method and the reference method as proven by the student’s t-test and the variance-ratio F-test values that did not exceed the theoretical ones. The analytical Eco-Scale and the analytical GREEness metric (AGREE) were the tools utilized for greenness assessment. This CZE procedure is the first electro-driven separation method that was utilized for the analysis of both antibiotics in their combined laboratory-prepared tablets with no interference from the co-formulated adjuvants.

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Section: Resultsmentioning

confidence: 87%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Development, validation and greenness assessment of a new electro-driven separation method for simultaneous analysis of cefixime trihydrate and linezolid in their fixed dose combination

Habeeb,

Morshedy,

Daabees

et al. 2023

BMC Chemistry

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A Green Three-Ratio Manipulating Spectrophotometric ApproachesFor the determination of a binary mixture of pantoprazole and domperidone

Abuseada,

Sattar,

Madkour

et al. 2024

Preprint

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Pantoprazole (PAN), a proton pump inhibitor, is widely prescribed to treat gastrointestinal disorders such as gastroesophageal reflux disorder (GERD), and hyperacidity. Suppressing gastric acid secretion effectively alleviates symptoms like heartburn, acid regurgitation, and indigestion. Domperidone (DOM), a prokinetic agent, that enhances gastrointestinal motility is often prescribed with PAN in patients with additional motility disorders. This combination is useful for patients who suffer from nausea, vomiting, or bloating due to motility dysfunction. (Pantosec-D) tablets contain both PAN and DOM This combination provides rapid relief from gastrointestinal symptoms by addressing both acid-related and motility-related issues. This combination ensures better management of gastrointestinal problems by enhancing the patient's comfort and quality of life. The establishment and validation of three spectrophotometric techniques—the ratio difference (RD), the first derivatives (1DD), and the mean centering (MC) methods of the ratio spectra—for determining PAN and DOM in combined pharmaceutical formulations are presented in this study. These methods are based on manipulating the ratio spectra of the cited medications to resolve their spectral overlapping, including the RD, 1DD, and MC methods. DOM was measured using the RD method, which calculated the amplitude difference between 209 and 233 nm. Conversely, PAN was evaluated by determining the 254 and 223 nm amplitude differences. DOM and PAN were shown to be selectively determined at 215 nm and 249 nm, respectively, using the first derivatives of the ratio spectra approach. PAN was evaluated at 254 nm in the mean centering method, whereas DOM was specifically quantified at 209 nm. The suggested procedures were verified in compliance with ICH regulations. Pharmaceutical formulations comprising PAN and DOM were effectively analyzed using the linear correlations obtained for both drugs over concentration ranges of zero–52 µg/mL and 1–18 µg/mL, respectively. Compared with reported chromatographic methods, these techniques provide easy-to-use, reasonably priced, and dependable substitutes for the standard quality control of these medications in mixed dosage forms.

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Development, Validation and Greenness Assessment of Three Simple Spectrophotometric Methods for Determination of Two Combined Broad-Spectrum Antibacterial Agents

Cited by 2 publications

References 0 publications

Development, validation and greenness assessment of a new electro-driven separation method for simultaneous analysis of cefixime trihydrate and linezolid in their fixed dose combination

Development, validation and greenness assessment of a new electro-driven separation method for simultaneous analysis of cefixime trihydrate and linezolid in their fixed dose combination

A Green Three-Ratio Manipulating Spectrophotometric ApproachesFor the determination of a binary mixture of pantoprazole and domperidone

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