Spectrophotometric analysis of Azithromycin and its pharmaceutical dosage forms: Comparison between Spectrophotometry and HPLC

Sharmin, Nahid; Shanta, Nazia Sultana; Bachar, Sitesh C.

doi:10.3329/dujps.v12i2.21981

Cited by 10 publications

(3 citation statements)

References 25 publications

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“…Because of the low release profiles(brand A2), local sources may need to improve some practices, and regulatory authorities may need to increase monitoring of the quality of pharmaceutical products manufactured by local industries. Similar results were reported from India [ 6 ], and Bangladesh [ 58 ]. However, the dissolution result of the finding different from the study done in Belgium [ 18 ], and Cameroon [ 17 ].…”

Section: Discussionsupporting

confidence: 90%

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia

Tefera

Chali²,

Feissa³

et al. 2023

PLoS ONE

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Background Azithromycin is a therapeutically” relevant macrolide antibiotic registered on the Essential Medicines List of the World Health Organization. The fact that medicine is selected as an essential drug doesn’t mean that it is of good quality. Hence, a continuous quality evaluation of the drug should be mandated to verify that the right medication is available on the market. Objective To evaluate the quality of Azithromycin Tablets commonly marketed in Adama, and Modjo town, Oromia Regional State, Ethiopia. Methods All six brands were subjected to in-vitro quality control tests, which were carried out according to procedures described in the manufacturer’s method, the United States Pharmacopeia, and the WHO inspection tool. All quality control parameters were compared by one-way ANOVA. Statistically, significant difference was considered when P<0.05. The in-vitro dissolution profiles of the brands were also compared statistically using the post-hoc Dunnett test, model-independent and model-dependent approaches. Results All of the evaluated brands agreed with WHO visual inspection criteria. All of the tablets achieved the thickness, and diameter test requirements of the manufacturer’s specification (±5%). All brands passed the hardness, friability, weight variation, disintegration, identity, and assay tests as stipulated by USP. The dissolution rate was more than 80% in 30 minutes, which was within the USP specification. The model-independent parameters have confirmed that only two brands (2/6) were deemed better brands for interchangeability. Weibull and Korsemeyer’s Peppas model were the best release models. Conclusion All of the evaluated brands passed the quality specification. The model dependent approaches revealed that drug release data fit well to the Weibull, and Korsemeyer’s Peppas release models. However, the model-independent parameters have confirmed that only two brands were deemed better brands (2/6) for interchangeability. Due to the dynamic nature of low-quality medications, the Ethiopian Food, and Drug Authority should keep an eye on marketed products to guarantee their quality, especially for drugs like azithromycin for which non-bioequivalence data from the study has revealed a clinical concern.

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Section: Discussionsupporting

confidence: 90%

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia

Tefera

Chali²,

Feissa³

et al. 2023

PLoS ONE

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“…There is a need to analyze pharmaceutical formulations of AZM qualitatively and quantitatively. The absorption of AZM in raw materials, biological samples, and pharmaceutical formulations is determined by many techniques, such as high-performance liquid chromatography (HPLC), , mass spectrometry (MS), Fourier transform infrared spectroscopy, UV–vis spectroscopy, LC–MS, and electrochemical methods. , All above mentioned methods have some limitations such as being inflated, time-consuming, requiring rigorous sample preparation, and being laborious. In comparison to UV–vis spectrometry, Raman scattering is preferable as it is perceived in a single-beam mode which uses no reference channel to minimize instrumental sensitivity.…”

Section: Introductionmentioning

confidence: 99%

Qualitative and Quantitative Analysis of Azithromycin as Solid Dosage by Raman Spectroscopy

Shahbaz,

Tariq,

Majeed

et al. 2023

ACS Omega

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Active pharmaceutical ingredients (APIs) and excipients are main drug constituents that ought to be identified qualitatively and quantitatively. Raman spectroscopy is aimed to be an efficient technique for pharmaceutical analysis in solid dosage forms. This technique can successfully be used in terms of qualitative and quantitative analysis of pharmaceutical drugs, their APIs, and excipients. In the proposed research, Raman spectroscopy has been employed to quantify Azithromycin based on its distinctive Raman spectral features by using commercially prepared formulations with altered API concentrations and excipients as well. Along with Raman spectroscopy, principal component analysis and partial least squares regression (PLSR), two multivariate data analysis techniques have been used for the identification and quantification of the API. For PLSR, goodness of fit of the model (R 2 ) was found to be 0.99, whereas root mean square error of calibration was 0.46 and root mean square error of prediction was 2.42, which represent the performance of the model. This study highlights the efficiency of Raman spectroscopy in the field of pharmaceutics by preparing pharmaceutical formulations of any drug to quantify their API and excipients to compensate for the commercially prepared concentrations.

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“…1). Literature reveals few spectrophotometric methods [18][19][20][21][22][23] and two fluorimetric assays [24,25] for determination of AZN in bulk and formulations. A detailed review for RSGL estimation [26] is reported, without direct fluorimetric technique.…”

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confidence: 99%

Carbon dots as fluorescent nanoprobes for assay of some non-fluorophoric nitrogenous compounds of high pharmaceutical interest

Moustafa

Talaat

Youssef

et al. 2023

Beni-Suef Univ J Basic Appl Sci

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Background Carbon dots, CDs, have excellent photoluminescence properties, good biocompatibility, low toxicity and good light stability. The optical, magnetic and electronic properties of CDs make them a hugely relevant tool to be used in pharmaceutical analysis, bioimaging, drug delivery, and other fields. The fluorescence of carbon nanodots makes it suitable for assay of some nitrogenous compounds of high pharmaceutical interest. In this work, we develop simple, fast and green spectrophotometric methods for quantification of Azithromycin and Rasagiline mesilate using synthesized fluorescent CDs from garlic peels. Results The spectrometric methods depend on stoichiometric reactions of both drugs with fluorescent CDs. Carbon dots exhibit a declared absorption peak λmax at 238 nm and potent fluorimetric emission at λem 528 nm, upon excitation at λex 376 nm. Drugs’ concentrations in ppm are efficiently calculated using Stern–Volmer Equation. Decrease in fluorescence (ΔF = Fo − F) and the F-ratio values are linearly correlated to molar concentration of each quencher (drug). A significant linear diminish in the dots’ measured absorbance and fluorimetric emission values was observed. Validation of all the developed methods was according to the ICH guidelines. Conclusions In a new way, this work successfully indicates, spectrometric methods for rapid detection of two non-fluorophoric nitrogenous compounds using potent carbon nanodots. Consequently, these green developed methods offer several benefits as simplicity, ease of quantification, accuracy and precision that encourage the application of the developed methods in routine analysis of Azithromycin and Rasagiline mesilate in quality control laboratories as analytical tool.

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Spectrophotometric analysis of Azithromycin and its pharmaceutical dosage forms: Comparison between Spectrophotometry and HPLC

Cited by 10 publications

References 25 publications

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia

Qualitative and Quantitative Analysis of Azithromycin as Solid Dosage by Raman Spectroscopy

Carbon dots as fluorescent nanoprobes for assay of some non-fluorophoric nitrogenous compounds of high pharmaceutical interest

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