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Relevant bibliographies by topics / Analytical Method Development and Validation. RP-HPLC

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Academic literature on the topic 'Analytical Method Development and Validation. RP-HPLC'

Author: Grafiati

Published: 5 June 2025

Last updated: 2 August 2025

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Journal articles on the topic "Analytical Method Development and Validation. RP-HPLC"

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Prajakta, G.Thete* and Ravindra B. Saudagar. "REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 05 (2018): 4897–907. https://doi.org/10.5281/zenodo.1286144.

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Analytical method development, validation, and transfer are essential elements of any pharmaceutical development program. Effective method development confirms that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development. High performance liquid chromatography is most accurate methods extensively used for the qualitative and quantitative analysis of drug product. Analytical method development and validation play vital role in the drug discovery, Drug development and manufacture of pharmaceuticals. It includes detection of the purity and

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Jinal, Harshadkumar Rathod *. Jaymin G. Patel Bhumi R. Patel. "ESTIMATION OF CLOTRIMAZOLE, CLINDAMYCIN PHOSPHATE AND TINIDAZOLE BY VARIOUS ANALYTICAL METHOD: REVIEW ARTICLE." Journal of Pharma Research 8, no. 4 (2019): 160–68. https://doi.org/10.5281/zenodo.2647870.

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<strong><em>ABSTRACT</em></strong> <strong><em>A</em></strong><em>nalytical method development and its validation is an important aspect in drug discovery process. Development of analytical method producing accurate and precise data is necessary to ensure the quality and safety of the drugs. At present, the most common analytical method employed for estimation of drugs is Reverse Phase High Pressure Liquid Chromatography (RP-HPLC) because of its high sensitivity, accuracy and speed. Different types of analytical methods are available for estimation of Clindamycin Phosphate, Clotrimazole and Ti

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Gopal, Lohiya Saurabh Rahatkar Rohini Ghotmukale Swapnali Delmade Kranti Satpute Sanket Dharashivkar Surendra G. Gattani Sunny Chauhan Sudhanshu Kumar Jha* Divyam Maheshwari. "RP HPLC Method Development and Validation on OLAPARIB Tablets." International Journal in Pharmaceutical Sciences 1, no. 9 (2023): 227–40. https://doi.org/10.5281/zenodo.8332607.

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Analytical technique’s is a wide-ranging concept covering all matters that individually or collectively influence the quality of the product. Highly specific and sensitive analytical techniques hold the key role to the design, development, standard and quality control of medicinal products. Quality of drug products is very vital, as it involves life. Proper manufacture and quality control of pharmaceuticals is the vital segment of strong primary healthcare program worldwide. Pharmaceutical analysis, a branch of pharmacy, plays a very significant role in quality control of pharmaceuticals

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Mashru, Rajashree, Hemangi Parekh, and Parin Chokshi. "Analytical Method Development and Validation for the Estimation of Sugammadex." Journal of Drug Delivery and Therapeutics 10, no. 1 (2020): 52–59. http://dx.doi.org/10.22270/jddt.v10i1.3842.

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A simple, precise, accurate, specific RP-HPLC method developed for sugammadex in bulk and simulated mixture. Chromatographic separation is achieved by C18 column (250 x 4.6 mm, 5µ) in isocratic mode. The optimized mobile phase consists of acetonitrile and double distilled water in ratio of 20:80%v/v at a flow rate of 0.5mL/min and sugammadex was monitored at 210nm. Retention time of the drug was found to be 3.39min. The linearity obtained in range of 50 – 250 µg/mL. %RSD mean for precision and %Recovery mean of the sugammadex were found to be 0.63 and 99.04% - 99.84% respectively. Stability in

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Kakad, Gayatri, Sandhya L. Borse, Atul R. Bendale, Laxmikant B. Borse, Vaishali D. Naphade, and Anil G. Jadhav. "Analytical Method Development and Validation Protocol for Antiepileptic Agent – Rufinamide." Asian Pacific Journal of Health Sciences 9, no. 4 (2022): 208–13. http://dx.doi.org/10.21276/apjhs.2022.9.4s1.38.

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This study developed and validated a new, sensitive, appropriate, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for determining Rufinamide in bulk medication and tablet formulation. The separation was performed using an HPLC method with a UV detector and Openlab EZ chrome workstation programme, Kromasil C18, 250 mm X 4.6mm ID, 5 μm column, Methanol: 0.025% TFAA (60:40%V/V) was pumped at a flow rate of 1.0 mL/min and detected at 212 nm. The new RP-HPLC method resulted in a 3.22minute retention time for Rufinamide, which was optimized by trial

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Putta, Prapulla. "Analytical Methods Development and Validation of Naproxen and Sumatriptan by RP HPLC." International Journal of Trend in Scientific Research and Development Volume-3, Issue-4 (2019): 325–27. http://dx.doi.org/10.31142/ijtsrd23582.

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*Krishnaphanisri, Ponnekanti, Anusha Addanki, Raj Kamal B., Bhavani Dasari Durga, Reddy Gargula Sumana, and Reddy Karnati Shiva. "A REVIEW-ON METHOD DEVELOPMENT & METHOD VALIDATION BY RP-HPLC FOR ESTIMATION OF ARFORMOTEROL." World Journal of Pharmaceutical Science and Research 4, no. 2 (2025): 1062–70. https://doi.org/10.5281/zenodo.15364947.

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Arformoterol is a long-acting β<sub>2</sub> adrenoreceptor agonist (LABA) and it is the active (<em>R</em>,<em> R</em>)-(−)enantiomer of formoterol. It was approved for medical use in the United States in October 2006. It is available as a generic medication. Arformoterol is indicated for the maintenance treatment of bronchoconstriction in people with chronic obstructive pulmonary disease (COPD). The purpose of analytical method development is to establish the identity, purity, physical characteristics, and potency of drugs, including the drug’s bioavailability and stability.

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Lokhande, Dr Pradnya. "Analytical Method Development and Validation of Teneligliptin by using RP-HPLC with ICH Guidelines." International Journal of Trend in Scientific Research and Development Volume-3, Issue-3 (2019): 259–63. http://dx.doi.org/10.31142/ijtsrd21735.

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Mohammad, Tarikul Islam Bossunia, Farjana Urmi Khandokar, and Chironjit Kumar Shaha. "Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation." Pharmaceutical Methods 8, no. 2 (2017): 01–10. https://doi.org/10.5281/zenodo.14856243.

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Context: Stability Indicating RP-HPLC analytical method validation for estimation of Canagliflozin API have been reported, but there are not studies related to the application of Analytical Quality by Design (AQbD) concepts to the development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API). Aim: Development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API) according to An

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Lohiya, G. V. Mahima Jadhav Rohini Ghotmukle Shivnechari P. M. Birajdar M. J. Kulkarni Y. P. Satpute K. L. "RP HPLC Method Development and Validation on Dapagliflozin." International Journal of Pharmaceutical Sciences 2, no. 7 (2024): 1766–79. https://doi.org/10.5281/zenodo.12806716.

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Analytical techniques encompass a broad spectrum of methods and practices essential for ensuring the quality of medicinal products. These techniques are crucial for the design, development, standardization, and quality control of pharmaceuticals. The quality of drug products is paramount because it directly impacts patient safety and treatment efficacy. Therefore, stringent manufacturing processes and quality control measures are indispensable components of robust primary healthcare systems globally.Pharmaceutical analysis, a specialized area within pharmacy, is pivotal in maintaining the qual

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Dissertations / Theses on the topic "Analytical Method Development and Validation. RP-HPLC"

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Lindholm, Johan. "Development and Validation of HPLC Methods for Analytical and Preparative Purposes." Doctoral thesis, Uppsala : Acta Universitatis Upsaliensis, Univ.-bibl. [distributör], 2004. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4442.

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Amann, Laura. "Development and Validation of an Analytical Method for Phenolic Acid Extraction from Cereals and Quantification using HPLC-UV." Thesis, Linnéuniversitetet, Institutionen för kemi och biomedicin (KOB), 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-77227.

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Cereals are rich in phenolic acids, a group of secondary plant metabolites that are associated with reduced risk of chronic diseases. The objective was to develop and internally validate a method for extraction and quantification of phenolic acids in cereals using HPLC-UV and to apply this method for quantification of the content of phenolic acids in several species of Swedish cereals. Different procedures for extraction of phenolic acids from cereal grains using acid or base hydrolysis with and without subsequent enzymatic treatment were tested. Both the extraction procedure and the chromatog

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LA, MAIDA NUNZIA. "Development and validation of analytical methods with hyphenated chromatographic techniques for the determination of NPS and drugs of abuse in biological matrices." Doctoral thesis, Università Politecnica delle Marche, 2022. https://hdl.handle.net/11566/299808.

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Sin dal 1990 l'apparizione sul mercato di nuove sostanze psicoattive (NPS) è un fenomeno mondiale sempre crescente. Ogni anno vengono introdotte nuove sostanze nel mercato della droga come alternative legali alle sostanze controllate dalla legge. L’identificazione di queste nuove sostanze in matrici biologiche rappresenta una continua sfida per i laboratori di analisi. È estremamente importante sviluppare metodologie analitiche in grado di identificare sostanze sconosciute consentendone il monitoraggio e fornendo informazioni scientifiche riguardo la farmacocinetica, possibili range di tossici

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Pingeon, Marine. "Development and validation of analytical methods for therapeutic drug monitoring." Doctoral thesis, Universita degli studi di Salerno, 2019. http://elea.unisa.it:8080/xmlui/handle/10556/4509.

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2017 - 2018<br>The U.S. Food and Drug Administration defines as Precision or Personalized Medicine (PM) an innovative therapeutic approach that tailors therapy and prevention on patients based on inter-individual variabilities in molecular or environmental features and in lifestyles. The major goals of PM are to maximize treatment efficacy and to reduce cost, toxicities and therapy failure rates by early identification of patients who might benefit or not of a specific treatment. In this scenario, therapeutic drug monitoring (TDM) is an important laboratory tool for PM because of the poss

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Swiha, Stéphanie. "Optimisation du suivi de l'exposition aux hydrocarbures aromatiques polycycliques pendant la grossesse avec le développement et la validation de méthodes analytiques et biologiques Analysis of polycyclic aromatic hydrocarbons in human biological samples Development of an analytical method for the simultaneous quantitation of 24 regulated Polycyclic Aromatic Hydrocarbons (PAHs) in maternal and umbilical cord sera Validation of the analytical procedure for the determination of 22 regulated polycyclic aromatic hydrocarbons in maternal and umbilical cord sera." Thesis, Sorbonne Paris Cité, 2019. http://www.theses.fr/2019USPCB020.

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Les Hydrocarbures Aromatiques Polycycliques (HAP) sont principalement émis par les activités humaines et représentent l'un des principaux groupes de polluants dans l'air, les sols, les eaux et les aliments. Par conséquent, ils font l'objet d'une surveillance atmosphérique, et alimentaire. Cette étude s'attache au cas particulier de la femme enceinte et son fœtus. En effet, l'exposition pendant la grossesse est à l'origine de malformations fœtales, de prématurité et de troubles pouvant survenir ensuite chez l'enfant mais aussi chez l'adulte. À ce jour, seuls quelques HAP réglementés par l'envir

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Cahyana, A. "Development, validation and application of an analytical method for the determination of fucose in human plasma after oral administration of fucoidan." Thesis, 2016. https://eprints.utas.edu.au/23423/1/Cahyana_whole_thesis.pdf.

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Background: It has been reported that fucoidan, a polysaccharide commonly extracted from brown seaweeds, possesses a wide range of biological activities. Fucoidan is composed of a highly negatively charged and polydispersed oligosaccharides having fucose as the main component. It is not possible to separate various oligosaccharides of intact fucoidan using only one method because of their high negative charge, high molecular weight and polydispersity. Fucoidan is commercially available in the oral dosage form (only available as capsules). However, its bioavailability after oral administration

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Ennis, Nicole. "Development of new analytical methods for the analysis of an emerging pharmaceutical pollutant (ibuprofen): analysis by capillary electrophoresis and HPLC coupled with off-line SPE." Master's thesis, 2017. http://hdl.handle.net/10400.1/10234.

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Dissertação de mestrado, Qualidade em Análises, Faculdade de Ciências e Tecnologia, Universidade do Algarve, 2017<br>Pharmaceuticals have become priority emerging environmental pollutants. Environmental monitoring and toxicological studies are essential to establish maximum permissible limits in the environment. Furthermore, innovative wastewater treatment is required for their degradation. Águas do Algarve is constructing an aerobic granule plant to modernize wastewater treatment for the cities of Faro and Olhão. The company is interested in research regarding granule ability to degrade

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Book chapters on the topic "Analytical Method Development and Validation. RP-HPLC"

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Roja, Aavula, Peram Uma Maheshwari, Ramapuram Munemma, and Konda Swathi. "Method Development and Validation of Gallic Acid in Liquid Dosage Form by Using RP-HPLC Method." In Advances in Experimental Medicine and Biology. Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-31986-0_51.

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K, Shah Chandra, Dr Dedania Zarna, Dr Dedania Ronak, and Dr Jain Vineet C. "ANALYTICAL QBD APPROACH TO HPLC METHOD DEVELOPMENT AND VALIDATION FOR PREGABALIN." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 19. Iterative International Publisher, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bgpn19p1ch6.

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Analytical QbD helps to provideanalytical life cycle management by systemic method development and maintenance. An efficient CCD - Central Composite Design was developed at 23 factorial designs; mobile phase composition and pH kept as two different factors at law(-1), medium(0) and high(+1) at three levels for RP-HPLC method. The response to be evaluated being retention time, peak asymmetry and theoretical plates. The chromatographic separation conditions were optimized with the Design Expert Software version10.0.1.0, i.e. Inertsil ODS column C18 (250×4.6mm, 5.0µm), mobile phase used werephosp

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"HPLC Method Development and Optimization with Validation in Mind." In Handbook of Analytical Validation. CRC Press, 2012. http://dx.doi.org/10.1201/b12039-5.

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Moldoveanu, Serban C., and Victor David. "Method and data validation in high-performance liquid chromatography analysis." In Method Development in Analytical HPLC. Elsevier, 2025. https://doi.org/10.1016/b978-0-443-29849-3.00010-5.

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Boddu, Veeraswami, and Kasinath Baratam. "Analytical Method Development and Validation of Triamcinolone Acetonide by Using RP-HPLC Technique." In Current Innovations in Chemical and Materials Sciences Vol. 8. B P International, 2024. http://dx.doi.org/10.9734/bpi/cicms/v8/8418a.

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Kumar, Meruva Sathish, Phani Deepika Polampalli, Bandi Narendar, S. Siva Prasad, and Rasapally Ramesh Kumar. "Analytical Method Development and Validation of Simultaneous Estimation of Ivermectin and Albendazole Byusing RP-HPLC." In Novel Aspects on Chemistry and Biochemistry Vol. 7. B P International (a part of SCIENCEDOMAIN International), 2023. http://dx.doi.org/10.9734/bpi/nacb/v7/6574e.

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Pavani, Bonagiri, Narender Malothu, D. S. N. B. K. Prasanth, and Chakravarthi Guntupalli. "Quantification of Daridorexant in Human Plasma Using RPHPLC: A Bioanalytical Method Development and Validation." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00211.

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A novel analytical approach for quantifying Daridorexant (DXT) in plasma has been devised using suvorexant as an internal standard (IS), To separate the DXT from the plasma, liquid-liquid extraction (LLE) was utilized, followed by RP-HPLC analysis using a PDA. DXT recovery was tested with several extraction solvents (n-butyl chloride, ether / toluene (1: 1), and methyl t-butyl ether (MTBE)). Analytes were separated on an Inertsil ODS column (250 x 4.6 mm, 5µ) using a 0.5 mM sodium acetate buffer (pH-3.5): methanol (78:22 v/v) as mobile phase pumped at 0.5 mL/min. The temperature in the column

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Shreya, N. Naik, Desai Shuchi, and Bijal Patel. "Analytical Method Development and Validation for Simultaneous Estimation of Nadifloxacin and Mometasone Furoate in Semisolid Dosage Form by RP-HPLC Method." In Novel Aspects on Pharmaceutical Research Vol. 5. B P International (a part of SCIENCEDOMAIN International), 2023. http://dx.doi.org/10.9734/bpi/napr/v5/6532a.

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Solanki, Binal, and Hirak Joshi. "Recent Development and Validation of a RP-HPLC Analytical Method for the Simultaneous Determination of Luliconazole and Clobetasol Propionate in Synthetic Mixture." In Current Aspects in Pharmaceutical Research and Development Vol. 5. Book Publisher International (a part of SCIENCEDOMAIN International), 2021. http://dx.doi.org/10.9734/bpi/caprd/v5/2854e.

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Mercado, Roberto, Silvia Lagos, and Ethel Velásquez. "Radiochemical Purity and Identity in Radiopharmaceuticals: Design and Improvement of Quality Control Methods by HPLC." In Advances in Dosimetry and New Trends in Radiopharmaceuticals. IntechOpen, 2023. http://dx.doi.org/10.5772/intechopen.112355.

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The radiopharmaceutical supply chain involves rigorous quality control tests to assure products are safe and effective to use in the clinic. However, one of the key challenges for analytical methods in radiopharmacy is the narrow time frame where the analysis must be completed due to the limited half-life of radiomolecules. Radiochemical purity and identity are critical tests to control the success of radiolabeling. These parameters are easily determined by thin-layer chromatography methods (TLC) in some widely used molecules such as [18F]FDG. However, for new diagnostic and therapeutic agents

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Conference papers on the topic "Analytical Method Development and Validation. RP-HPLC"

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Ruttanakorn, Kanong, Apipawat Detpan, Mongkol Thongkham, et al. "Development of a Validated RP-HPLC Method for Quantification of Four Bioactive Phenolic Compounds from Mulberry Leaf Infusion." In 5th International Conference and Exhibition on Pharmaceutical Sciences and Technology 2022. Trans Tech Publications Ltd, 2022. http://dx.doi.org/10.4028/p-bey5s1.

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The aim of this work was to develop and validate RP-HPLC method for quantification of 4 major polyphenolic compounds of mulberry leaf infusion. The mulberry leaf samples were extracted by simulation of tea infusion beverage preparation. HPLC-DAD analysis combined with column C-18 150 mm x 4.6 mm, 2.7 μm was used to determine bioactive polyphenols such as chlorogenic acid, caffeic acid, rutin, and quercetin. The optimal conditions involved the flow rate of mobile phase at 0.3 ml/min with gradient elution of 0.1% formic acid in water and methanol, column temperature at 35 °C, 2 μl injection volu

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Kumar, Praveen, Meenu Chaudhary, Vaibhav Rathi, Bhupendra Singh, Manish Vyas, and Geetanjali Saini. "Validated analytical method development for drug residue (Clonazepam) in pharmaceutical industries by RP-HPLC." In THE FOURTH SCIENTIFIC CONFERENCE FOR ELECTRICAL ENGINEERING TECHNIQUES RESEARCH (EETR2022). AIP Publishing, 2023. http://dx.doi.org/10.1063/5.0162987.

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Al-Samarrai, Saif Dahham Hameedi, and Eman Thiab Al-Samarraie. "Development and validation of RP-HPLC method analysis for COVID-19 antiviral drug Samavir tablet." In 1ST SAMARRA INTERNATIONAL CONFERENCE FOR PURE AND APPLIED SCIENCES (SICPS2021): SICPS2021. AIP Publishing, 2022. http://dx.doi.org/10.1063/5.0120911.

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Hardeep, Narendra Kumar Pandey, Sachin Kumar Singh, Bimlesh Kumar, Ankit Awasthi, and Leander Corrie. "Simple and robust RP-HPLC method development and validation for estimation of simvastatin in self-nanoemulsifying drug delivery system." In 14TH INTERNATIONAL CONFERENCE ON MATERIALS PROCESSING AND CHARACTERIZATION 2023. AIP Publishing, 2024. http://dx.doi.org/10.1063/5.0192442.

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Patil, Sushil, Sunil Amurutkar, and C. Upasani. "A stability indicating RP-HPLC method development and validation for the estimation of combined tablet formulation of Amlodipine & Candesartan." In 4th International Electronic Conference on Medicinal Chemistry. MDPI, 2018. http://dx.doi.org/10.3390/ecmc-4-05585.

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M, Akiful, Sandeep Reddy, Gowri Mulagada, and Vasudha Bakshi. "Development and validation of RP-HPLC method for the estimation of Tigecycline in bulk and its parenteral dosage form." In MOL2NET 2018, International Conference on Multidisciplinary Sciences, 4th edition. MDPI, 2018. http://dx.doi.org/10.3390/mol2net-04-05635.

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Ow, Hooisweng, Sehoon Chang, Gawain Thomas, Wei Wang, Afnan A. Mashat, and Hussein Shateeb. "Automatable High Sensitivity Tracer Detection: Toward Tracer Data Enriched Production Management of Hydrocarbon Reservoirs." In SPE Annual Technical Conference and Exhibition. SPE, 2021. http://dx.doi.org/10.2118/206338-ms.

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Abstract The development of automatable high sensitivity analytical methods for tracer detection has been one of the most central challenges to realize ubiquitous full-field tracer deployment to study reservoirs with many cross-communicating injector and producer wells. Herein we report a tracer analysis approach, inspired by strategies commonly utilized in the biotechnology industry, that directly addresses key limitations in process throughput, detection sensitivity and automation potential of state-of-the-art technologies. A two-dimensional high performance liquid chromatography (2D-HPLC) m

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Honjo, Shintaro, Shunsaku Matsumoto, and Takeshi Sano. "Maximizing Production with Real-Time Integrity Operating Windows." In Offshore Technology Conference. OTC, 2021. http://dx.doi.org/10.4043/31030-ms.

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Abstract A conceptual design of digital Intelligent Production Integrity Operating Windows (IP-IOW) system, which is an unique and transformational solution to the oil and gas offshore industry focusing on maximizing production while optimizing equipment operation, was developed through a Nippon Foundation (NF) - DeepStar® partnership project. This connects the fluids system with the equipment system using IP-IOW architecture and specifications of a digital platform. The developed digital IP-IOW architecture contains five major evaluation modules, which are Component risk analysis (CRA), Failu

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