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Mankar, S. D.
- Review on Development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography
Abstract Views :76 |
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Authors
H. S. Jumde
1,
S. D. Mankar
2
Affiliations
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, IN
2 Department of Pharmaceutics, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, IN
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, IN
2 Department of Pharmaceutics, Pravara Rural College of Pharmacy, Loni, 413736, Maharashtra, IN
Source
Asian Journal of Pharmacy and Technology, Vol 12, No 2 (2022), Pagination: 179-182Abstract
RP-HPLC is the most, sensitive, universal analytical procedure. It is extremely versatile tech where analytes are separated by passes through column of different sized particles. Analytical method development ensures the specific characteristics of the drug substances against the preconceived acceptance criteria, while method meets objectives required at each stage of development of drug which is a continuous process, and should be robust and accessible. Validation of analytical method demonstrates the scientific firmness of measurement or characterization and is required throughout the regulatory submission process and the main purpose of validation of API is to demonstrate that it maintains the desired level of compliance and also suitable for its intended purpose.Keywords
RP-HPLC, Validation, Column, Analytical, Flow Rate, Mobile PhaseReferences
- HEMA, G. Swetha Reddy, 2017. A Review on New Analytical Method Development and Validation Using RP-HPLC, et al.
- Method development and validation of pharmaceuticals by different instrumental techniques: a review by Sabyasachi Biswal Sumanta mondal, H K Sandep Kumar, International Journal of Pharmaceutical Science Reviews and Research. 2018.
- Akul Mehta (Dec 27, 2012). Principle of reverse-phase chromatography HPLC/UPLC. Pharmaxchange. Retrieved 10 Jan 2013.
- Amersham Biosciences. Reverse Phase Chromatography Principles and Methods. page 9-10.
- R.E Majors, LCGC 15 (11), 1008-1015 (1997).
- Ronald E. Majors, Agilent Technologies, Wilmington Delaware, USA, The cleaning and regeneration of reverse phase HPLC column, LC.GC Europe (Jul 2003)
- Snyder LR, Kirkland JJ, Glajch JL: Practical HPLC method development. 2nd ed. 2001.
- Kar A: pharmaceutical Drug analysis. 1st edition 2001; 565-592.
- Amesham bioscience: reverse phase chromatography. Principles and methods, page. 6-8.
- Sethi PD: HPLC Quantitative Analysis of Pharmaceutical Formulation. CBS Publishers and Distributors, 1st edition 2001.
- Biosimilar and it’s Current Perspective – A Review
Abstract Views :86 |
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Authors
Affiliations
1 Pravara Rural College of Pharmacy, Pravaranagar, IN
1 Pravara Rural College of Pharmacy, Pravaranagar, IN
Source
Research Journal of Pharmacology and Pharmacodynamics, Vol 14, No 2 (2022), Pagination: 84-88Abstract
Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. The term “biosimilar” is in common use in the European Union, while the term “follow on biologics” is more popular in the American context. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as “biological generics”. These are rather unique molecules with limited data at time of approval, so there are concerns about the safety and efficacy of biosimilars. The Indian biotechnology industry is also gaining momentum, with revenues of over U.S. $ 2.0 billion in 2006, 70% of which is biopharmaceuticals. These are projected to reach up to $580 million in 2012.This article will address the differences between biosimilars and chemical generics, issues of concern with the use of biosimilars and need of appropriate regulations for their approval.Keywords
Biosimilar, Chemical generic, Current status, Issues concern, FDA approach.References
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- Biosimilar medicines: Overview [Internet]. London (UK): European Medicines Agency; c1995–2018 [cited 2019 Jan 5]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/ge neral/general_content_001832.jsp&mid=WC0b01ac0580bb8fda. Accessed 5 Jan 2019
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- Aladul, M.I.; Fitzpatrick, R.W.; Chapman, S.R. Healthcare professionals’ perceptions and perspectives on biosimilar medicines and the barriers and facilitators to their prescribing in UK: A qualitative study. BMJ Open 2018, 8, 11 e023603.
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- Park, S.K.; Moon, W.; Kim, E.S.; Park, S.H.; Park, D. Il Knowledge and Viewpoints on Biosimilar Monoclonal Antibodies among Asian Physicians: Comparison with European Physicians. Korean J. Gastroenterol. 2019, 74, 333–340.
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- Kounis Syndrome: A Novel Review
Abstract Views :71 |
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Authors
Affiliations
1 Pravara Rural College of Pharmacy, Pravaranagar (Loni BK), Ahmednagar, Maharashtra, 413736, IN
1 Pravara Rural College of Pharmacy, Pravaranagar (Loni BK), Ahmednagar, Maharashtra, 413736, IN
Source
Research Journal of Pharmacology and Pharmacodynamics, Vol 14, No 3 (2022), Pagination: 165-170Abstract
Kounis syndrome is characterised by a group of symptoms that manifests as unstable vasospastic or nonvasospastic angina secondary to a hypersensitivity reaction. It was first described by Kounis and Zavras in 1991 as the concurrence of an allergic response with an anaphylactic or anaphylactoid reaction and coronary artery spasm or even myocardial infarction. Since then, this condition has evolved to include a number of mast cell activation disorders associated with acute coronary syndrome. There are many triggering factors, including reactions to multiple medications, exposure to radiological contrast media, poison ivy, bee stings, shellfish, and coronary stents. In addition to coronary arterial involvement, Kounis syndrome comprises other arterial systems with similar physiologies, such as mesenteric and cerebral circulation resulting in ischemia / infraction of the vital organs. The Incidence of this condition is difficult to establish owing to the number of potential instigating factors and its relatively infrequent documentation in the literature. Anaphylaxis rarely manifests as a vasospastic acute coronary syndrome with or without the presence of underlying coronary artery disease. The variability in the underlying pathogenesis produces a wide clinical spectrum of this syndrome. Kounis syndrome is not just a single organ but also a complex multisystem and multiorgan arterial clinical conditions, it affects the coronary, mesenteric, and cerebral arteries and is accompanied by allergy hypersensitivity anaphylaxis involving Skin , respiratory system and vascular system in the context of anaesthesia, surgery, radiology ,oncology or even dental and psychiatric medicine , further it has significantly influences both morbidity and mortality. Kounis syndrome is caused by inflammatory mediators released during allergic insults, post inflammatory cell activation and interactions via multi directional stimuli. A platelet subset of 20% with high and low affinity IgE surface receptors is also involved in this process.Keywords
Acute coronary syndrome, Mast cell, Histamine, Leukotriene, Kounis syndrome.References
- Sarfaraz Memon, Lovely Chabra, Shihab Masrur, and Matthew W. Parker, Allergic acute coronary syndrome (Kounis Syndrome) Baylor University Medical Centre Proceedings 2015 Jul; 28(3):358-362
- Nicholas G. Kounis, George Hahalis, Akrivi Manola, Taxiarchis V Kourelis, Kounis syndrome (allergic angina and allergic myocardial infarction), Research Gate, In: Angina Pectoris: Etiology, Pathogenesis and Treatment ISBN: 978-1-60456-674-1 2008 Nova Science Publishers, Inc.
- Nicholas G. Kounis, Loanna Koniari, Cesare de Gregorio, Dimitris Velissaris, Konstantinos Petalas, Aikaterina Brinia, Stelios F. Assimakopoulos, Christos Gogos, Sophia N. Kounis, George N. Kounis, Gian Franco Calogiuri and Ming Yow Hung. Allergic reactions to current available COVID-19 vaccinations: Pathophysiology Causality And Therapeutic considerations, MDPI, Vaccines 2021, 9,221. https://doi.org/10.3390/vaccines903022
- Tajda Keber, Jana Makuc, and Gregor Sekavinik, Case report Type 1 Kounis Syndrome in Patient with idiopathic Anaphylaxis, Hindawi Case reports in Cardiology Volume 2017, Article ID 1089023, 3 pages
- Prof. Dr. Johnson Francis, Kounis Syndrome, All about cardiovascular system and disorders, December 5, 2014, General Cardiology
- Mahmoud Abdelghany, Rogin Subedi, Siddharth Shah, Hani Kozman, Kounis syndrome: A review article on epidemiology, diagnostic findings, managements and complications of allergic acute coronary syndrome National Library of Medicine 2017Apr 1;232:1-4.doi:10.1016/j.ijcard.2017.01.124.Epub 2017 Jan 27
- Venkataramanan Gangadharan, Samit Bhateja, and Kais Al Balbissi Kounis Syndrome- an Atopic monster for the heart, Cardiovasc Diagn Ther.2013 Mar; 3(1): 47-51
- Parackrama Karunathilake, Udaya Ralapanawa, Thilak Jayalath, and Shamali Abeyagunawardena. Kounis Syndrome secondary to Medicine induced Hypersensitivity, Hindawi, Volume 2021 Article ID 4485754 https://doi.org/10.1155/2021/4485754
- Sukhyanti Kerai, Lalit Sehrawat, Kirti Nath Saxena and Bharti Taneja. Occurrence of Kounis syndrome under anesthesia, Journal of Anaesthesiology, Clinical Pharmacology, Volume 33, Issue 2, April- June 2017
- Dean Chan Pin Yin, Jaouad Azzahhafi and Stefan James, Risk assessment using Risk Scores in Patients with Acute coronary syndrome, Journal of Clinical Medicine, 2020,9(9),3039, 21 September 2020
- Jingang Zheng, Yifeng Zhou, Xiaofei Lei, Wenhua Peng, Acute coronary syndrome secondary to allergic coronary vasospasm (Kounis syndrome): A case series, follow up and literature review, Springer,18, Article number: 42(2018), 27 February 2018
- Mattia Giovannini Loanna Koniari, Francesca Mori, Silvia Ricci, Luciano De Simone, Silvia Favilli, Sandra Trapani, Giuseppe Indolfi, Nicholas George Kounis, Elio Novembre, Kounis Syndome: a clinical entity penetrating from paediatrics to geriatrics, 299, Journal of Geriatric Cardiology (2020)17:29.
- A Review Article on Analytical Methods Development and Validation
Abstract Views :104 |
PDF Views:0
Authors
Affiliations
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, IN
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, IN
Source
Research Journal of Science and Technology, Vol 14, No 1 (2022), Pagination: 77-83Abstract
Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.Keywords
Method development, Validation Parameter, Accuracy, System suitability, LOD, LOQReferences
- Hema, Swati Reddy G. A review on new analytical method development and validation by RP-HPLC. Int Res J Pharm Biosci 2017;4:41-50.
- Sharma, Shivani, Swapnil Goyal, and Kalindi Chauhan. A review on analytical method development and validation. International Journal of Applied Pharmaceutics (2018): 8-15.
- Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step by-step analytical method validation. IOSR J Pharm 2015;5:7-19.
- Sharp JR. The Problems of Process Validation. Pharm J 1986; 1:43-5.
- Chauhan A, Mittu B, Chauhan P. Analytical method development and validation: a concise review. J Anal Bioanal Tech 2015;6:1.
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- South African Guide to Good Manufacturing Practice. Pretoria: Medicines Control Council, 1996. http://www.pharmanet.co.za/mcc /inpectorate/ins-71998.htm.
- Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issued for Development and Validation. Washington DC: US Food and Drug Administration, 1994.
- Agalloco J. Validation: an unconventional review and reinvention, PDA J. Pharm Sci Tech 1995; 49, 175–179.
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- R Tambe, S Mankar, S Dighe - Analytical Method Development and Validation of Paliperidone: A Review, Research Journal of Science and Technology, 2020, Vol-12, Issue-01,23-35