Green Analytical Chemistry: Opportunities for Pharmaceutical Quality Control

2016 ◽  
Vol 71 (9) ◽  
pp. 899-909
Author(s):  
A. B. Eldin ◽  
O. A. Ismaiel ◽  
W. E. Hassan ◽  
A. A. Shalaby
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Green Analytical Chemistry ◽  
Pharmaceutical Quality

Green analytical chemistry: Opportunities for pharmaceutical quality control

2016 ◽  
Vol 71 (9) ◽  
pp. 861-871 ◽  
Author(s):  
A. B. Eldin ◽  
O. A. Ismaiel ◽  
W. E. Hassan ◽  
A. A. Shalaby
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Green Analytical Chemistry ◽  
Pharmaceutical Quality

Atorvastatin: A Review of Analytical Methods for Pharmaceutical Quality Control and Monitoring

2019 ◽  
Vol 102 (3) ◽  
pp. 801-809
Author(s):  
Ana Carolina Kogawa ◽  
Ana Elisa Della Torre Pires ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Analytical Methods ◽  
Pharmaceutical Products ◽  
Point Of View ◽  
Human Consciousness ◽  
Pharmaceutical Samples ◽  
Pharmaceutical Quality ◽  
The Impact

Abstract Background: Atorvastatin, a lipid-regulating drug, was the best-selling drug in the world in the early 2000s. Thus, monitoring of this drug is important because it is accessible to a large portion of the population. In addition, its quality control is fundamental to provide quality medicines. Method of analysis can be the first step in the rational use of pharmaceuticals. Objective/Methods: In this context, a critical review of analytical methods present in the literature and official compendia for the pharmaceutical quality control of atorvastatin was made. Results: Among the analytical methods most used in the evaluation of atorvastatin, HPLC is highlighted, followed by HPLC coupled to MS, and spectrophotometry in UV. Tablets are the most studied pharmaceutical samples, and plasma is the most studied biological matrix. In the literature, studies with atorvastatin-based pharmaceutical products are more common than biological materials. Acetonitrile is the organic solvent most commonly used in the methods surveyed to evaluate atorvastatin. Conclusions: Currently, awareness of the impact that the analytical choice has on the health of the operator and the environment is growing. Therefore, the suitability of existing methods for the determination of atorvastatin can be made to adhere to the current analytical chemistry. In this way, the analytical, environmental, and human consciousness will remain united. Highlights: Although the literature shows interesting methods from an economic and environmental point of view, such as UV, Vis miniaturized, and TLC, they can still be improved to meet the requirements of the current sustainable analytical chemistry.

Turbidimetric Method: A New, Ecological, and Fast Way to Evaluate of Vancomycin Potency

2020 ◽  
Vol 103 (6) ◽  
pp. 1582-1587
Author(s):  
Patrícia Aleixa do Nascimento ◽  
Ana Carolina Kogawa ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Culture Medium ◽  
Culture Media ◽  
Pharmaceutical Product ◽  
Green Analytical Chemistry ◽  
Microbiological Method ◽  
Turbidimetric Method ◽  
Microbiological Methods ◽  
Routine Quality Control

Abstract Background Vancomycin, an antimicrobial, has many microbiological methods in literature, but it was not found any that follows the green chemistry principles. Objective The aim of this work was to develop and validate a new microbiological analytical method with a green view to determine the vancomycin potency in lyophilized powder using less quantity of diluents and culture medium, minimizing the costs and reducing the time of analysis. Methods The objective will be achieved using the microbiological method by turbidimetry. Results Water was used as the diluent to prepare the vancomycin solution. BHI broth as used as culture media for the growth of the S. aureus ATCC 25923. The method was linear in the range of 30, 39 and 50.7 µg/mL. It was selective, with vancomycin reference and sample absorbance values very similar. The precision of the method was proved at intraday (RSD 4.42 %), interday (RSD 3.56 %) and intermediate levels (RSD 2.03%). It was accurate with mean recovery of 100.71 % and robust when changes were performed in three parameters of the method and analyzed by the F-Test and t-Test. Conclusions The method for evaluating the potency of vancomycin in pharmaceutical product was successfully developed and validated. Highlights The method can be applied to routine quality control of vancomycin product as an alternative that contemplates the green analytical chemistry and the current pharmaceutical analyzes.

scholarly journals ECO-FRIENDLY GREEN LIQUID CHROMATOGRAPHIC FOR DETERMINATION OF DOXYCYCLINE IN TABLETS AND IN THE PRESENCE OF ITS DEGRADATION PRODUCTS

2018 ◽  
Vol 2 (2) ◽  
pp. 49-55
Author(s):  
Loren Ghidini ◽  
Ana Kogawa ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Degradation Products ◽  
Toxic Waste ◽  
Green Analytical Chemistry ◽  
Photolytic Degradation ◽  
Liquid Chromatographic ◽  
Detection And Quantification ◽  
Routine Quality Control

Doxycycline, an oral antimicrobial, does not present a sustainable analytical method described in the literature using liquid chromatography. A new and efficient method was developed and validated for the quantification of doxycycline tablets by HPLC-UV. Its aim is the contribution to the green analytical chemistry since it has low use of organic solvent and low production of toxic waste. The HPLC-UV method used a mixture of purified water + 0.5 % acetic acid and ethanol (40:60, v/v). The flow rate was 0.8 mL min-1, C18 Luna column, 20 μL of injected volumes at 275 nm. The samples were prepared in purified water and the method was linear over the concentration range of 20–200 μg mL-1 (r = 0.9997) with limits of detection and quantification of 1.08 and 3.27 μg mL-1, respectively. The precision of the method showed RSD 0.50 % (intra-assay), 2.35 % (inter-assay) and 1.13 % (between analysts). The accuracy of the method was determined by standard recovery and it was 99.85 %. The DOX tablets were subjected to oxidative, acid, basic, neutral and photolytic degradation and it showed be stability indicative. Statistical analysis provided reliable, safety and reproducible results. The method is considered linear, selective, precise, accurate, robust, indicative of stability and safe to be used in routine quality control analyzes for determination and quantification of doxycycline in tablets. The proposed method is an ecologically correct alternative for the evaluation of doxycycline tablets.

A New Ecological HPLC Method for Determination of Vancomycin Dosage form

2020 ◽  
Vol 7 (2) ◽  
pp. 82-90
Author(s):  
Patricia Aleixa do Nascimento ◽  
Ana Carolina Kogawa ◽  
Hérida R.N. Salgado
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Acetic Acid ◽  
Dosage Form ◽  
Uv Light ◽  
Hplc Method ◽  
Green Analytical Chemistry ◽  
Vancomycin Dosage ◽  
Routine Quality Control

Aims: To develop and validate a new ecological HPLC method for the determination of vancomycin dosage form. Background: Vancomycin is an important antimicrobial. According to the literature, there are many methods that use HPLC, but none of these methods follow the green analytical chemistry principles. Objective: Therefore, a green analytical method to quantify vancomycin in lyophilized powder for injectable solution by HPLC was developed. Materials and Methods: 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, and C18 column (15 cm) at 280 nm were used. Results and Discussion: 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 a 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 analyses.

scholarly journals Eco-friendly and miniaturized analytical method for quantification of Rifaximin in tablets

2019 ◽  
Vol 3 (2) ◽  
pp. 23-29
Author(s):  
Clara Motta ◽  
Ana Kogawa ◽  
Marlus Chorilli ◽  
Hérida Salgado
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Analytical Method ◽  
Low Cost ◽  
Ultraviolet Region ◽  
Waste Generation ◽  
Green Analytical Chemistry ◽  
Average Recovery ◽  
Relative Standard ◽  
A Current

Rifaximin is an oral antimicrobial, semisynthetic and nonabsorbable with minimal adverse effects that act locally in the gastrointestinal tract. Rifaximin does not have standardized methods of analysis for the tablets evaluation in official compendiums. The objective of this study is to develop and validate an analytical method for the quantification of rifaximin in tablets by spectrophotometry in the ultraviolet region, aiming at a miniaturized and eco-friendly method. The method was performed using 700 μL cuvette and purified water: ethanol (4:1, v/v) as diluent. The wavelength used was 233 nm and the range of concentrations was 4-14 µg mL-1. It was linear with correlation coefficient greater than 0.9999, precise with relative standard deviation equal 0.80%, 1.19% and 1.19% for intraday, interday and interanalyst precision, respectively, exact with average recovery of 100.56%, selective against the presence of interferents such as impuruties, matrix compouds and solvents used and robust with the change of ethyl alcohol brand and proportion used as diluent. The method developed presents advantages as, minimum waste generation, reduction in amount of sample, standard and solvents used and reduction in time of analysis. Then this method can be used in rotine analysis of rifaximin tablets as a alternative method, reliable, effective, really fast, low cost, eco-friendly and miniaturized. This study contemplates a current and innovative topic which is extremely important for the area of Quality Control of drugs and medicines and for the sustainable Green Analytical Chemistry.

System errors of manufacturers of medicines detected by conducting of state control in the area of circulation of medicines

2019 ◽  
Vol 2019 (5) ◽  
pp. 32-38
Author(s):  
Валентина Косенко ◽  
Valentina Kosenko ◽  
Алла Трапкова ◽  
Alla Trapkova ◽  
Светлана Тарасова ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Management Systems ◽  
State Control ◽  
Quality Management Systems ◽  
Conducting State ◽  
Pharmaceutical Quality ◽  
State Quality ◽  
System Errors

The article conducts the analysis of system errors detected by Roszdravnadzor by conducting state quality control of circulating medicines, as well as weaknesses in pharmaceutical quality management systems of the manufacturers, that can influence the quality of manufactured drugs.

scholarly journals Combining Normal/Reversed-Phase HPTLC with Univariate Calibration for the Piperine Quantification with Traditional and Ultrasound-Assisted Extracts of Various Food Spices of Piper nigrum L. under Green Analytical Chemistry Viewpoint

Molecules ◽  
2021 ◽  
Vol 26 (3) ◽  
pp. 732
Author(s):  
Mohammed H. Alqarni ◽  
Prawez Alam ◽  
Ahmed I. Foudah ◽  
Magdy M. Muharram ◽  
Faiyaz Shakeel
Keyword(s):  
Analytical Chemistry ◽  
High Performance ◽  
Black Pepper ◽  
Reversed Phase ◽  
Normal Phase ◽  
Piper Nigrum ◽  
Green Analytical Chemistry ◽  
Pharmaceutical Samples ◽  
Analytical Technique ◽  
Ultrasound Assisted

Due to unavailability of sustainable analytical techniques for the quantitation of piperine (PPN) in food and pharmaceutical samples, there was a need to develop a rapid and sensitive sustainable analytical technique for the quantitation of PPN. Therefore, the current research presents a fast and highly sensitive normal/reversed-phase high-performance thin-layer chromatography (HPTLC) technique with classical univariate calibration for the quantitation of PPN in various food spices of black pepper with traditional (TE) and ultrasound-assisted extracts (UBE) of various food spices of Piper nigrum L. under green analytical chemistry viewpoint. The amount of PPN in TE of four different spices of black pepper—namely BPMH, BPLU, BPSH, and BPPA—was found to be 309.53, 304.97, 282.82, and 232.73 mg g−1, respectively using a sustainable normal-phase HPTLC technique. However, the amount of PPN in UBE of BPMH, BPLU, BPSH, and BPPA was recorded as 318.52, 314.60, 292.41, and 241.82 mg g−1, respectively using a sustainable normal phase HPTLC technique. The greenness of normal/reversed-phase HPTLC technique was predicted using AGREE metric approach. The eco-scale was found to be 0.90, suggested excellent greenness of normal/reversed-phase technique. UBE of PPN was also found to be superior over TE of PPN. Overall, the results of this research suggested that the proposed normal/reversed-phase densitometry technique could be effectively used for the quantitation of PPN in food and pharmaceutical samples.

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