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Journal articles on the topic 'Validation of analytical method'

Author: Grafiati

Published: 4 June 2021

Last updated: 26 July 2025

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1

Helaskar, Chandrashekhar Bhagvatrao, and S. R. Kulkarni. "Analytical method development and validation for Aluminium." International Journal of Research and Development in Pharmacy & Life Sciences 7, no. 4 (2018): 3034–38. http://dx.doi.org/10.21276/ijrdpl.2278-0238.2018.7(4).3034-3038.

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Mahapatra, Asmita, and Chandanam Sreedhar. "HPLC AND ANALYTICAL METHOD VALIDATION : A REVIEW." Indian Research Journal of Pharmacy and Science 5, no. 1 (2018): 1399–414. http://dx.doi.org/10.21276/irjps.2018.5.1.18.

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3

Kim, Yoo-Gon, Houng-Seok Seo, and Chan-Hee Won. "Analytical method validation of oxiracetam using HPLC." Analytical Science and Technology 23, no. 6 (2010): 587–94. http://dx.doi.org/10.5806/ast.2010.23.6.587.

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4

Mukesh, Patil* Roshani Dhumal Ashish Jain Srushti Kadave Aishwarya Patil. "A Review: Analytical Method Development and Validation." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 2350–65. https://doi.org/10.5281/zenodo.14506358.

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In the process of finding new drugs, analytical development and validation are crucial. It is a continuous and inter-dependent task linked with research and development, quality assurance and quality control department. Analytical method development and validation helps to demonstrate that the technique developed it precise, accurate, linear, and robust, as well as specific to analyse a drug in pharmaceutical industry. The essential part of a study is developing the analytical methodology. Advancement in analytical instruments lead to recent development in analytical methods. The excipients, a

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Sushila, Dagadu Chavan, and Mahendra Desai Deepa. "Analytical method validation: A brief review." World Journal of Advanced Research and Reviews 16, no. 2 (2022): 389–402. https://doi.org/10.5281/zenodo.7785494.

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Validation is an applied approach to verify that a method is suitable to function as a quality control tool. The objective of any analytical measurement is to obtain consistent, reliable and accurate data. Validated analytical methods play a major role in achieving this goal. An analytical method consists of the techniques, method, procedure and protocol. Analytical method validation includes the determination of accuracy, precision, LOD, LOQ, linearity and range. The results from method validation can be used to moderator the quality, reliability and consistency of analytical results, which i

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6

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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Singh, Jitender, Sonia Sangwan, Parul Grover, Lovekesh Mehta, Deepika Kiran, and Anju Goyal. "Analytical Method Development and Validation for Assay of Rufinamide Drug." Journal of Pharmaceutical Technology, Research and Management 1, no. 2 (2013): 191–203. http://dx.doi.org/10.15415/jptrm.2013.12012.

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8

Swati, Raysing, Patil Mansi, and Patil Aditya. "Analytical Method Development and Validation: A Concise Review (Review Article)." International Journal of Pharmacy and Biological Sciences 11, no. 1 (2021): 09–16. http://dx.doi.org/10.21276/ijpbs.2021.11.1.2.

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A Patel, Sachin. "A Review on Analytical Method Development and Validation for Lusutrombopag." International Journal of Science and Research (IJSR) 12, no. 4 (2023): 1321–23. http://dx.doi.org/10.21275/sr23419114521.

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10

Patel, Jigar Rambhai. "Studies of Analytical Method Validation of Some Antiashthamatic Drugs for Futured Intended Analytical Application." Indian Journal of Applied Research 4, no. 3 (2011): 47–48. http://dx.doi.org/10.15373/2249555x/mar2014/15.

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11

*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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12

Acutis, Marco, Patrizia Trevisiol, Roberto Confalonieri, et al. "Analytical Method Performance Evaluation (AMPE)A Software Tool for Analytical Method Validation." Journal of AOAC INTERNATIONAL 90, no. 5 (2007): 1432–38. http://dx.doi.org/10.1093/jaoac/90.5.1432.

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Abstract A Windows-based software tool [Analytical Method Performance Evaluation (AMPE)] was developed to support the validation of analytical methods. The software implements standard statistical approaches commonly adopted in validation studies to estimate analytical method performance (limits of detection and quantitation, accuracy, specificity, working range, and linearity of responses) according to ISO 5725. In addition, AMPE proposes the application of innovative and unique approaches for the assessment of analytical method performance. Specifically, AMPE proposes the use of difference-b

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13

Vijaya, Kumar Meher, Gautam Girendra, Prasad Meher Chaitanya, and Kumar Patro Saroja. "A Recent Review On Analytical Method Development and Validation." American Journal of PharmTech Research 12, no. 5 (2022): 49–65. https://doi.org/10.5281/zenodo.7270167.

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ABSTRACT In this review articles, the development, formulation, and manufacture of drugs, analytical method development & validation play a critical role. Methods are developed for ensuring purity, identity, potency, and performance of pharmaceutical products. Methods should be applied to the extent that they are sufficient for their intended purpose. Throughout the life cycle of a drug product and substance, a range of activities are associated with developing and validating methods. An objective of method validation is to prove that the procedure can be used as intended. Once the method

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14

Chan, Chung Chow. "Principles and Practices of Analytical Method Validation: Validation of Analytical Methods is Time-consuming but Essential." Quality Assurance Journal 14, no. 3-4 (2011): 61–64. http://dx.doi.org/10.1002/qaj.477.

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15

Sushila Dagadu Chavan and Deepa Mahendra Desai. "Analytical method validation: A brief review." World Journal of Advanced Research and Reviews 16, no. 2 (2022): 389–402. http://dx.doi.org/10.30574/wjarr.2022.16.2.1165.

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Validation is an applied approach to verify that a method is suitable to function as a quality control tool. The objective of any analytical measurement is to obtain consistent, reliable and accurate data. Validated analytical methods play a major role in achieving this goal. An analytical method consists of the techniques, method, procedure and protocol. Analytical method validation includes the determination of accuracy, precision, LOD, LOQ, linearity and range. The results from method validation can be used to moderator the quality, reliability and consistency of analytical results, which i

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16

Hibbert, D. B. "Method validation of modern analytical techniques." Accreditation and Quality Assurance 4, no. 8 (1999): 352–56. http://dx.doi.org/10.1007/s007690050381.

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17

Indu, Gurram* M.V.S.Kavitha M.V.Nagabhushnam Brahmaiah Bonthagara D.Nagarjuna Reddy. "OVERVIEW OF VALIDATION, BASIC CONCEPTS AND ANALYTICAL METHOD PROCESS VALIDATION." Indo American Journal of Pharmaceutical Sciences 04, no. 06 (2017): 1665–80. https://doi.org/10.5281/zenodo.821850.

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Quality is the primordial intention to any industry and its products manufactured. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. Validation is the art of designing and practicing the designed steps alongside with the documentation. Validation and quality assurance will go hand in hand, ensuring the through quality for the products. When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to

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18

Shashi, Daksh, and Goyal Anju. "Analytical Method Development and Validation: A Review." Chemistry Research Journal 5, no. 3 (2020): 173–86. https://doi.org/10.5281/zenodo.12589409.

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<strong>Abstract </strong>This review focuses on approach to the validation of HPLC method with the compliance of restrictive needs and accepted pharmaceutical practices. The information during this review provides the explanations for performing analytical method validation. The validation parameters needed to be performed in validation for assay and organic impurities strategies. Individual validation parameters are mentioned in reference to the kind of method such assay and organic impurities method to be valid. This review was written to assist chemists/analysts to perform for method valid

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19

Bruce, P., P. Minkkinen, and M. L. Riekkola. "Practical method validation: Validation sufficient for an analysis method." Mikrochimica Acta 128, no. 1-2 (1998): 93–106. http://dx.doi.org/10.1007/bf01242196.

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20

Dinesh Singh, D. B. Joshi, and R. S. Bhadauria. "Analytical Method Validation for UV Spectroscopic Assay Method of Trypsin-Chymotrypsin Tablets." Journal of Biomedical and Pharmaceutical Research 12, no. 3 (2023): 50–59. http://dx.doi.org/10.32553/jbpr.v12i3.996.

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It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. T

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21

Mohd., Ibrahim, Goyal Rakesh, and Agarwal Dilip. "DEVELOPMENT AND VALIDATION BY HPLC METHOD." International Journal of Current Pharmaceutical Review and Research 14, no. 03 (2022): 104–7. https://doi.org/10.5281/zenodo.12658787.

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Validation of an analytical procedure is the process of demonstrate with suitable for itsintended purpose. Chromatographic such HPLC methods play significant role in thepharmaceutical industry from the drug discovery, development of drugs, formulations andquality control of chemicals. Many validated analytical methods ensure that it providesconsistent, reliable and accurate data for results. So these methods help pharmaceuticalanalyst to ensure quality products are released for market. This review explains generalapproach for validation process and validation parameters to be considered during

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22

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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23

VLN, SAGAR, SHARMA GVR, OMPRAKASH G, and BHARAT KB. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR RELATED SUBSTANCE IN OLANZAPINE BY HPLC." Indian Research Journal of Pharmacy and Science 3, no. 3 (2016): 763–72. http://dx.doi.org/10.21276/irjps.2016.3.3.5.

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24

Biswal, Sabyasachi, and Sumanta Mondal. "Analytical Method Validation Report for Assay of Lapatinib by UPLC." Pharmaceutical Methods 10, no. 1 (2019): 6. https://doi.org/10.5281/zenodo.14586180.

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Objective: A new, simple, rugged, rapid, robust and precise ultra-performance liquid chromatographic (UPLC) method for estimation of Lapatinib in a bulk and tablet dosage form has been developed and validated according to ICH Guidelines. Methods: The chromatographic separation was achieved using BHEL UPLC Column. The mobile phase used was a mixture of 0.1% OPA buffer 300 ml (30%) and 700ml Acetonitrile (70%) at isocratic mode and eluents were monitored at 309 nm using PDA detector. Results: By the method Lapatinib was eluted with retention time of 0.516 mins. The method was continued and valid

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25

Pawanpreet, Kaur* and Baljeet Singh. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE: A REVIEW." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 06 (2018): 5065–70. https://doi.org/10.5281/zenodo.1286729.

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Analytical method development and validation is an integral part during the development of drug substance and drug product in the pharmaceutical industry. It plays important role in the discovery, development, manufacture and quality control of pharmaceuticals. Analytical methods are designed to determine the drug content in formulation, presence of impurities, separation of drug and its related impurities and degraded products. Validation of method proves that it can be suitable for its use in research and development and assures the reliability of proposed method. Now days, need of analytica

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26

Mayuri, Bhokare* Dr. Pradyumna Ige. "Analytical Method Development and Validation of Dapagliflozin By RP-HPLC Method In Tablet Dosage Form." International Journal of Pharmaceutical Sciences 2, no. 7 (2024): 1718–28. https://doi.org/10.5281/zenodo.12801306.

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The main aim of the present research work is to develop a sensitive, precise and accurate HPLC (High-Performance Liquid Chromatography) procedure for the selective estimation of Dapagliflozin. An isocratic separation of Dapagliflozin through column used was a Inertsil ODS-3V with dimensions of 150 mm length and 4.6 mm inner diameter, packed with 5μm particle utilizing mobile phase composition of Acetonitrile and Water, with a proportion of 50% Acetonitrile and 50% water (v/v).  The detection of the analyte was processed at the maximum wavelength of 223 nm and with 1 ml/min flow of the

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Amandeep, Kaur*and Monika Gupta. "DEVELOPMENT AND VALIDATION OF METHOD BY HPLC TECHNIQUES." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 07 (2018): 7057–65. https://doi.org/10.5281/zenodo.1325897.

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<em>The primary focus of the review article is on general approaches and considerations toward development of chromatographic methods for separation, identification, and quantification of compounds, which may be applied within the various functions in the drug development continuum. This article also discusses the issues and parameters that must be considered in the validation of analytical methods. At the end of the review, a scope of the present research study is covered.</em> <strong>Keywords: </strong><em>Introduction, Method development, Steps for HPLC method development, Method validatio

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Doltade, Mayuri, and Ravindranath Saudagar. "The Analytical Method Development and Validation: A Review." Journal of Drug Delivery and Therapeutics 9, no. 3 (2019): 563–70. http://dx.doi.org/10.22270/jddt.v9i3.2774.

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Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. The main purpose of the analytical method development and validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety. Analytical methodology development has become the essential activity of study. Recent development in analytical methods has been resulted from the advancement of analytical instruments. Analytical

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29

Sharma, Shivani, Swapnil Goyal, and Kalindi Chauhan. "A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION." International Journal of Applied Pharmaceutics 10, no. 6 (2018): 8. http://dx.doi.org/10.22159/ijap.2018v10i6.28279.

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The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated sam

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30

Yadav, Aarti, and Dubey Raghvendra. "Stability Indicating Analytical Method Development and Validation." International Journal of Pharmaceutical Sciences and Medicine 7, no. 11 (2022): 33–50. http://dx.doi.org/10.47760/ijpsm.2022.v07i11.003.

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This write-up provides a review on the stability indicating analytical method development and validation. This review provides a basic detail about analytical method development, stability indicating analytical methods and validation as per regulatory guidelines and current scenario. What kind of content required for analytical procedure, steps involve in development of stability indicating analytical procedure also described. Details of Validation and its parameter like Specificity, Linearity, Range, Accuracy, Precision, Detection limit, Quantitation limit, Robustness, System suitability test

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31

Patel, Advaita B. "Analytical Method Validation: Collation between International Guidelines." Asian Journal of Research in Chemistry 10, no. 6 (2017): 857. http://dx.doi.org/10.5958/0974-4150.2017.00143.2.

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32

Sampaio, Valdomiro de Freitas, Gilberto J. Padovan, Julio Sérgio Marchini, Luiz Marcellino de Oliveira, and Sebastião Sousa Almeida. "Rat brain polyamines: an analytical method validation." Jornal Brasileiro de Patologia e Medicina Laboratorial 46, no. 6 (2010): 455–61. http://dx.doi.org/10.1590/s1676-24442010000600005.

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33

Rozet, E., E. Ziemons, R. D. Marini, B. Boulanger, and Ph Hubert. "Quality by Design Compliant Analytical Method Validation." Analytical Chemistry 84, no. 1 (2011): 106–12. http://dx.doi.org/10.1021/ac202664s.

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34

Buchholz, Peter, and Sebastian Vastag. "Toward an analytical method for SLA validation." Software & Systems Modeling 17, no. 2 (2017): 527–45. http://dx.doi.org/10.1007/s10270-017-0604-y.

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35

Bhagat, Roshan, and Ravindranath B. Saudagar. "A Review on Analytical method Development and Validation." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 1064–67. http://dx.doi.org/10.22270/jddt.v9i3-s.2957.

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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 purposes 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 to

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36

Krutanjali, Nikumbh* Kiran Dhamak. "A Comprehensive Review on Analytical Methods for The Estimation of Pharmaceuticals." Int. J. in Pharm. Sci. 1, no. 6 (2023): 65–77. https://doi.org/10.5281/zenodo.8033494.

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A proper approach that enables the scientist to analyse the drug molecule in the most exact, precise, and simple manner is necessary for the process of developing new medications. Finding the optimum approach for method development is crucial for the quantitative and qualitative estimate of pharmaceuticals in analytical chemistry. This research aids the author in comprehending the many analytical methods that may be used in the drug development process, including spectroscopy, chromatography, electrochemical methods, electrophoretic analysis, flow injection, and hyphenated method. All of these

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37

Shrivastava, Suman, Pooja Deshpande, and S. J. Daharwal. "Key Aspects of Analytical Method Development and Validation." Journal of Ravishankar University (PART-B) 31, no. 1 (2019): 32–39. http://dx.doi.org/10.52228/jrub.2018-31-1-6.

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Development of a method is crucial for discovery, development, and analysis of medicines in the pharmaceutical formulation. Method validation could also be thought to be one in all the foremost well-known areas in analytical chemistry as is reproduced within the substantial variety of articles submitted and presented in peer review journals every year. Validation of an analytical procedure is to demonstrate that it's appropriate for its intended purpose. Results from method validation are often wont to decide the quality, reliability and consistency of analytical results. Analytical methods ne

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38

Pancham, Yogesh, Nikita Patil, Girish B, and Vinod Mannur. "Development and Validation of Analytical Method for Determination of Andrographolide in Bulk Powder." International Journal of Pharma Research and Health Sciences 7, no. 1 (2019): 2899–903. http://dx.doi.org/10.21276/ijprhs.2019.01.08.

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Bogantes-Molina, Joselyn, German Leonardo Madrigal-Redondo, Lorena Berrocal-Barrantes, Marianela Chavarría-Rojas, Daniel Alejandro Acuña-Amador, and Rolando Vargas-Zúñiga. "Analytical method validation for metformin quantification in dissolution medium." GSC Biological and Pharmaceutical Sciences 7, no. 2 (2019): 043–51. https://doi.org/10.5281/zenodo.4286158.

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Metformin hydrochloride is a hypoglycemic agent used for type II Diabetes Mellitus treatment, and one of the most used to manage it. The objective of the present work was the development and validation of an analytical method to quantify metformin hydrochloride in the dissolution medium by UV spectrophotometry. Linearity and range, accuracy and precision were the validation process parameters. Validation process results showed the analytical method was easy, quick, secure and, furthermore, a linear, accurate and precise method in the studied concentrations range.  Therefore, it is a relia

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Amol, Amrutkar, Aher Smita, and Bachhav Rishikesh. "A Comprehensive Review On Analytical Method Development And Validation." Int. J. in Pharm. Sci. 1, no. 2 (2022): 112–24. https://doi.org/10.5281/zenodo.6260581.

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The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated sam

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Ganesh, Tiwari* Viral Maheshwari Rohan Shakywanshi Rukhsar khan Dr. Bhoomi Patel. "Development of UV Spectroscopic Method of Dapagliflozin with Some Validation Parameter." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 42–54. https://doi.org/10.5281/zenodo.15317978.

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This research compiles information on the development of analytical methods for estimating Dapagliflozin, which will be valuable for future research on this drug and its impurities. The literature survey covers various analytical methods such as UV, RP-HPLC, HPTLC, and other techniques reported for Dapagliflozin, both alone and in combination with other drugs. The analysis of published data indicates that only a UV spectroscopic method (calibration curve method) has been reported for estimating Dapagliflozin in fixed-dose combination. Each technique is evaluated for its sensitivity, specificit

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42

Medvedevskikh, M. Yu, M. P. Krasheninina, A. S. Sergeeva, and V. B. Baranovskaya. "Validation of analytical methods: case study." Industrial laboratory. Diagnostics of materials 86, no. 8 (2020): 72–79. http://dx.doi.org/10.26896/1028-6861-2020-86-8-72-79.

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The study continues the research previously published in the article «Validation of analytical methods: the international requirements» (Zavod. Lab. Diagn. Mater. 2018. Vol. 84. No. 12, pp. 25 – 31). We consider the procedure and the results of validation of the measurement procedure for determination of the residual content of enrofloxacin in food using high performance liquid chromatography with mass spectrometric detection. The program of experimental studies and calculation formulas necessary to assess the metrological characteristics of the method are presented. Validation included assess

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43

Carda-Broch, Samuel, and Paul R. Haddad. "Method validation." Journal of Chromatography A 1353 (August 2014): 1. http://dx.doi.org/10.1016/j.chroma.2014.06.004.

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44

Gunjan, Rao, and Goyal Anju. "An Overview on Analytical Method Development and Validation by Using HPLC." Pharmaceutical and Chemical Journal 3, no. 2 (2016): 280–89. https://doi.org/10.5281/zenodo.13754273.

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HPLC is an analytical technique widely used for identification, separation, detection and quantification of various drugs and its related degradants. HPLC process development is important in case of drug discovery, drug development and in analysis of pharmaceutical products. It is also employed to separate the manufactured drugs and its related impurities. It also involves the understanding of physicochemical properties of drug substances; hence facilitate the development of analytical method. The article mainly focuses on optimization of HPLC method during process development and validation o

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45

Dewi, Mayang, Reza Pratama, Mia Arifka, and Anis Chaerunisaa. "Quality By Design: Approach to Analytical Method Validation." Sciences of Pharmacy 1, no. 1 (2022): 33–40. http://dx.doi.org/10.58920/sciphar01010033.

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A pharmaceutical industry is highly regulated by a quality policy in its management. The principles of Quality by Design (QbD) must be applied to ensure the development of pragmatic and systematic methods while managing the risks associated with analytical methods. Quality by Design (QbD) is a scientific way to develop easy and robust analytical techniques for critical analysis. Quality by Design (QbD) is a systematic approach to product or method development that starts with predetermined goals and uses a science and risk management approach to achieve product and method understanding. The co

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Vassault, A., A. Hulin, E. Chapuzet, J. Arnaud, and C. Giroud. "Verification/validation of the performances of analytical method." Annales de biologie clinique 68, no. 1 (2010): 247–94. http://dx.doi.org/10.1684/abc.2011.0562.

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Parmar, Kinjal A., Falguni B. Tandel, and Dinesh Rabari. "Analytical Method Development and Validation of Desloratadine Tablet." Research Journal of Pharmacy and Technology 8, no. 6 (2015): 693. http://dx.doi.org/10.5958/0974-360x.2015.00109.2.

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Enéas, Paula Cristina Rezende, Renata Barbosa de Oliveira, and Gerson Antônio Pianetti. "Oxcarbazepine: validation and application of an analytical method." Brazilian Journal of Pharmaceutical Sciences 46, no. 2 (2010): 265–72. http://dx.doi.org/10.1590/s1984-82502010000200013.

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Abstract:

Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. Th

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Favier, C., N. Degallier, and C. E. Menkès. "Analytical models approximating individual processes: A validation method." Mathematical Biosciences 228, no. 2 (2010): 127–35. http://dx.doi.org/10.1016/j.mbs.2010.08.014.

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Ozkan, Sibel A. "Analytical Method Validation: The Importance for Pharmaceutical Analysis." Pharmaceutical Sciences 24, no. 1 (2018): 1–2. http://dx.doi.org/10.15171/ps.2018.01.

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