Pharmaceutica Analytica Acta最新文献

{"title":"Using Signal Processing Techniques to Enhance the TemperatureMeasurements Using Nanohole Array Sensors","authors":"Masoud Modaresifar, G. Kowalski, D. Larson","doi":"10.4172/2153-2435.1000545","DOIUrl":"https://doi.org/10.4172/2153-2435.1000545","url":null,"abstract":"A signal processing approach to reducing noise in the observed transmission through nanohole array sensors used in a microscale calorimeter is presented. The results demonstrate that using rectification and moving average processes, a well-defined Extraordinary Optical Transmission (EOT)-temperature calibration curve can be developed in the presence of a moving light fringe pattern.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"26 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84356046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardization of Eclipta Alba by HPTLC, HPLC and AAS","authors":"A. Bhattacharjee, Arpan Chakraborty, D. Dutta, A. Sau, S. Chakraborty, N. Samanta, Biswas Ps, G. Mukhopadhyay","doi":"10.4172/2153-2435.1000541","DOIUrl":"https://doi.org/10.4172/2153-2435.1000541","url":null,"abstract":"The whole plant of bhringaraj (Eclipta alba) was dried and pulverized. The phytoconstituents of the pulverized plant material were extracted separately with two different solvents namely petroleum ether (hot percolation) and methanol (cold maceration) to carry out a comparative extraction efficiency of the above two solvents. β-sitosterol reported to have antiandrogenic, anticancer, antiinflammatory, antiprostatitic, antitumor, etc. activity, was selected as the active biomarker for quantification of the aforementioned plant material. HPTLC was carried out for quantification of the biomarker and obtained data was compared with HPLC data. Petroleum ether was found to be an effective extracting solvent for β sitosterol from E. alba as compared to methanol. The percentage content of β-sitosterol in E. alba methanolic and petroleum ether extract was found to be 0.10% and 4.65% w/w respectively by HPTLC whereas the percentage content of β-sitosterol in Eclipta alba petroleum ether extract was found to be 4.67 % w/w by HPLC. AAS data revealed the presence of the metals (ppm ± SEM) are within safety limits, copper (1.151 ± 0.031), chromium (0.528 ± 0.012), cadmium (0.021 ± 0.035), lead (0.860 ± 0.009), arsenic (0.081 ± 0.007), mercury (0.036 ± 0.010).","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"23 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77016688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ibio Number Assay and Erythropoietin Bioactivity: Comparison of theCalculated and the Stated Potencies of the Biological ReferencePreparations of Erythropoietin","authors":"P. Hermentin","doi":"10.4172/2153-2435.1000542","DOIUrl":"https://doi.org/10.4172/2153-2435.1000542","url":null,"abstract":"The potencies of the biological reference preparations of erythropoietin, assigned by the European Pharmacopoeia Commission on the basis of the normocythaemic and polycythaemic mouse bioassay for erythropoietin, have retrospectively been calculated by the author via the Ibio-number assay, a physicochemical assay based on capillary zone electrophoresis data that allows to calculate the potency of erythropoietin medicinal products. The retrospective analysis by the author of the capillary electrophoresis data of three collaborative studies published in 2004, 2007 and 2015 has revealed that the potencies assigned for erythropoietin reference preparations batch 1 and batch 2 (~130.0 IU/μg, each) have been stated ~5 % too low respectively ~10 % too low, whereas the potency stated for erythropoietin reference preparation batch 3 (~141.1 IU/μg) was confirmed (difference to the stated potency = -1.2%) and therefore free of doubts. Thus, erythropoietin medicinal products that have been calibrated against erythropoietin reference preparation batch 1 or batch 2 have been subject to the same error which was, however, within the error of the mouse bioassay and therefore not crucial. With respect to erythropoietin concentrated solution batch release according to the European Pharmacopoeia, the very broad criteria for erythropoietin identification via capillary zone electrophoresis (which is based on broad ranges defined for the various erythropoietin isoforms) could be replaced by a single and quite narrow Ibio-number range, which would provide a significant increase in assay precision and accuracy and hence in drug safety. Moreover, the Ibio-number assay could be a candidate physicochemical assay to replace the mouse bioassay in the quality control of erythropoietin batch release.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"30 1","pages":"1-12"},"PeriodicalIF":0.0,"publicationDate":"2017-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82770735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Notes and Reflections on Impedance Spectroscopy","authors":"M. Frechero","doi":"10.4172/2153-2435.1000544","DOIUrl":"https://doi.org/10.4172/2153-2435.1000544","url":null,"abstract":"Fil: Frechero, Marisa Alejandra. Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet - Bahia Blanca. Instituto de Quimica del Sur. Universidad Nacional del Sur. Departamento de Quimica. Instituto de Quimica del Sur; Argentina","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85618756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosimilar Drugs Market Future Trends in United States","authors":"G. Barkha, K. Praneeth","doi":"10.4172/2153-2435.1000543","DOIUrl":"https://doi.org/10.4172/2153-2435.1000543","url":null,"abstract":"USA is a largest market of biologics globally. Biosimilar market expected to represent CAGR of 62.2 % as the chances of growth of biosimilar market from $1.7 billion in 2014 to $30 billion by 2020. Currently USA is a very small market for biosimilar but it can grow as the largest contributor for biosimilars as major share (upto 10 %) of the global revenue is generated from USA. Biosimilar therapy is a very effective way of treating disease conditions like cancer, rheumatoid, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and many autoimmune disorders [1].","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"663 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86848802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Electrodes Based on Garlic for the Inhibition of the Free Radicals Effects","authors":"A. Chtaini, Hind Sâadane, M. Ennachete, A. Moutcine, El Qouatli","doi":"10.4172/2153-2435.1000569","DOIUrl":"https://doi.org/10.4172/2153-2435.1000569","url":null,"abstract":"A new electrode based on garlic is prepared to inhibit the effect of oxidative stress, often linked to the presence of an excess of free radicals. The electrode paste was prepared as a mixture of finely powdered of garlic together with graphite powder. The influence of variables such as the garlic loading and free radicals concentration was tested by square wave voltammetry (SWV), cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS). The obtained results were found in good correlation with garlic reputation.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"69 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2017-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75638542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sensitive and Selective Extraction-Free Spectrophotometric Assay ofChloroquine Phosphate in Pharmaceuticals Based on Ion-Pair Reactionwith Bromocresol Green and Bromocresol Purple","authors":"Nagib Qarah As, K. Basavaiah, N. Swamy","doi":"10.4172/2153-2435.1000539","DOIUrl":"https://doi.org/10.4172/2153-2435.1000539","url":null,"abstract":"Chloroquine Phosphate (CQP) is an antimalarial agent extensively used in the treatment of malaria. Two spectrophotometric methods, which are rapid, simple, selective and sensitive, are presented for the determination of CQP in bulk and dosage forms using two sulphonphthalein dyes: Bromocresol Green (BCG method) and Bromocresol Purple (BCP method). The methods are based on the formation of chloroform-soluble ion-pairs, when CQP is reacted with either dye, suitable for measurement at 420 nm in both the methods. The effects of reaction time, dye concentration and reaction medium were carefully studied and optimized. Under the optimum reaction conditions, Beer's law is obeyed overconcentration ranges 1-20 and 0.5-12 μg mL-1 CQP (base) for BCG method and BCP method respectively, with corresponding molar absorptivity values of 1.79 × 104 and 3.09 × 104 L mol-1 cm-1. The calculated limits of detection (LOD) and quantification (LOQ) are 0.27 and 0.82 μg mL-1 (BCG method); 0.15 and 0.46 μg mL-1 (BCP method). Intra-day and inter-day %RSD values were ≤1.56% and ≤1.83% whereas the respective %RE values were better than 2%. Robustness of the methods was determined by performing analysis with slightly altered optimum conditions while ruggedness was tested by inter-personnel as well as inter-equipment variations; the %RSD values were within the accepted limits in both instances. Method selectivity was as ascertained by placebo blank and synthetic mixture analysis with no detectable interference from co-formulated substances in the assays. The methods were applied to the determination of CQP in tablets, suspension and injections with satisfactory results. Accuracy was also confirmed by recovery test via standard-addition procedure.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"23 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2017-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81268374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Innovative Stability Indicating RP-HPLC Assay Method for theDetermination of Caroverine in Pharmaceutical Bulk and Tablets","authors":"A. Raza, Ansari Tm","doi":"10.4172/2153-2435.1000540","DOIUrl":"https://doi.org/10.4172/2153-2435.1000540","url":null,"abstract":"An innovative, quick and easy reversed phase high performance liquid chromatographic method is elaborated and authenticated for the quantitative determination of caroverine in pharmaceutical bulk material and tablets. Shimpack CLC-ODC (C18) column was used. The mobile phase acetonitrile and buffer solution (30:70) pH 4.9 is transmitted at a flow rate of 1 mL/min. The eluent was observed using UV detector at 225 nm. The recent developed RP-HPLC method is specific, accurate, precise and linear (R2>0.998) within the range of 2-150 μg/mL concentration. The limit of detection and quantification is 0.068 μg/mL and 0.201 μg/mL respectively. The newly proposed method is applied to determine caroverine in pharmaceutical tablet formulations. The developed method is optimized using samples generated by forced degradation studies. Results of analysis are validated statistically. The method was selective, precise, accurate and can be used for routine analysis of caroverine in quality control laboratories of pharmaceutical industries.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"40 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2017-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73451658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of Metoclopramide Hydrochloride in Pharmaceutical Formulations Using Three Different Spectrophotometric Methods","authors":"A. Naggar, Elnasr Tas, S. As, A. Kotb, El Sayed Aay","doi":"10.4172/2153-2435.1000538","DOIUrl":"https://doi.org/10.4172/2153-2435.1000538","url":null,"abstract":"Three simple, selective, accurate and precise spectrophotometric methods were developed for the determination of Metoclopramide Hydrochloride (MCP) in dosage forms. The first method (Method A) is based on coupling reaction of diazotized MCP with 2,5-diphenyl-2,4-dihydro-pyrazol-3-one (DPP) in alkaline medium to form azo dye. The second method (Method B) is based on Schiff’s base formation reaction between MCP and 4-hydroxybenzaldehyde (HBD). The last method (Method C) is based on the formation of colored ion–pair complex from the reaction of MCP with Eosin Y (ESN). Beer’s law was obeyed in the concentration range of 1.35-40.37, 1.01-5.05 and 1.01-10.09 μg/mL MCP at 426, 386 and 543 nm with molar absorptivity of 1.51×104 L mol-1 cm-1, 2.10×104 L mol-1 cm-1 and 3.34×104 L mol-1 cm-1 for Method A, Method B and Method C, respectively. The proposed methods were successfully applied to the determination of MCP in pharmaceutical preparations without any interference from common excipients.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"10 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2017-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87766591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ibio-Number Assay: A Physicochemical Assay that Predicts the Bioactivity of Erythropoietin with High Precision and Accuracy and May Replace the Mouse Bioassay in the Quality Control of EPO Batch Release","authors":"P. Hermentin","doi":"10.4172/2153-2435.1000533","DOIUrl":"https://doi.org/10.4172/2153-2435.1000533","url":null,"abstract":"The Ibio-number assay, based on capillary zone electrophoresis data of EPO samples, is evaluated as a physicochemical assay that enables to calculate the bioactivity of EPO medicinal products. In part 1, the CZE data of the candidate biological reference preparation EPO cBRP3 of a collaborative study of 10 laboratories (published in 2007) are used to calculate the bioactivity of EPO cBRP3 and to determine the interlaboratory precision of the assay and its accuracy against the stated bioactivity of EPO BRP3. This retrospective analysis by the author revealed an inter-laboratory precision of CV=0.8% (n=9 labs, 1 outlier lab excluded). The bioactivity calculated for cBRP3 (139.6 IU/μg), compared with the stated bioactivity of BRP3 (141.1 IU/μg=100%), provided an accuracy of 98.9%. In part 2, the CZE data of an epoetin alfa drug substance secondary standard and two epoetin alfa drug product samples (40,000 IU/mL and 2,000 IU/mL) from Centocor and two artificial epoetin beta concentrated solution samples from Roche (the mean of 40 epoetin beta ‘training batches’ and the mean of 17 epoetin beta ‘validation batches’) were retrospectively analyzed by the author using the Ibio-number assay. Moreover, the two hypothetical epoetin alfa/beta 1:1 mixtures of the Centocor and the Roche concentrated solution materials were prepared and the Ibionumber compared with the stated bioactivity of EPO BRP3. The results are summarized as follows: The Ibio-number assay applied to Centocor’s epoetin alfa secondary standard provided a potency of 142.3 IU/μg. The same assay applied to the mean of the 40 epoetin beta ‘training batches’ respectively the mean of the 17 epoetin beta ‘validation batches’ from Roche provided potencies of 133.8 IU/μg and 139.9 IU/μg, respectively. The two hypothetical alfa/beta 1:1 mixtures yielded bioactivities of 138.0 IU/μg and 141.1 IU/μg, respectively, which matched the stated bioactivity of BRP3 (141.1 IU/μg) with accuracies of 97.8% and 100.0%, respectively. The Ibio-number assay applied to Centocor’s formulated 40,000 IU/mL and 2,000 IU/mL epoetin alfa drug product samples revealed that the polysorbate 80 removal from the formulated samples decreased the bioactivity of the products by -1.7% (40 k sample) respectively -2.9% (2 k sample). This data demonstrates the suitability of the Ibio-number assay to calculate and compare the bioactivity of EPO samples with up till now unmet precision and accuracy. It is suggested that a prospective collaborative validation study will show that the Ibio-number assay is suitable to replace the mouse bioassay of EPO drug substance batch release, which will provide an increase in bioactivity precision and accuracy without any loss of product safety.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"36 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2017-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89414596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}