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Journal articles on the topic 'HPLC method development'

Author: Grafiati

Published: 5 June 2025

Last updated: 2 August 2025

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1

Snyder, Lloyd R., Joseph L. Glajch, Joseph J. Kirkland, and Richard W. Abbott. "Practical HPLC method development." Analytica Chimica Acta 245 (1991): 287–88. http://dx.doi.org/10.1016/s0003-2670(00)80235-4.

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2

Krull, L. S. "Practical HPLC Method Development." TrAC Trends in Analytical Chemistry 8, no. 9 (1989): 349–50. http://dx.doi.org/10.1016/0165-9936(89)87046-3.

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3

Schoenmakers, Peter. "Practical HPLC method development." Journal of Chromatography A 509, no. 2 (1990): 406–7. http://dx.doi.org/10.1016/s0021-9673(01)93100-0.

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4

Kennedy, John F., and Maria da Paz C. Silva. "Practical HPLC method development." Carbohydrate Polymers 16, no. 3 (1991): 338. http://dx.doi.org/10.1016/0144-8617(91)90119-w.

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Akash, Shelake* Mrs. Jaya D. kamble Dr. Nilesh Chougule. "HPLC Development Method and Validation." International Journal of Pharmaceutical Sciences 2, no. 11 (2024): 910–19. https://doi.org/10.5281/zenodo.14203300.

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Chromatography, while primarily a separation technique, is widely used in chemical analysis. High-performance liquid chromatography (HPLC) is a highly versatile technology that separates analytes by passing them through a column filled with micrometer-sized particles. Today, reversed-phase chromatography is the most extensively utilized separation technique in HPLC. This is due to the reversed-phase method's simplicity, versatility, and scope, which can handle compounds with a wide range of polarity and molecular mass.This article discusses tactics and difficulties for planning HPLC method dev

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Nikita, Pabale* Monali Khatke Mansi Shelke Vishweshwari Bhagat Tanvi Kamble. "A Review on HPLC Method Development and Validation." International Journal of Pharmaceutical Sciences, no. 11 (November 28, 2024): 1496–509. https://doi.org/10.5281/zenodo.14234238.

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High-Performance liquid chromatography (HPLC) is widely recognized as the most commonly used separation technique for the detection, separation, and quantification of drugs. To optimize HPLC methods, various chromatographic parameters are evaluated, including sample pretreatment, choice of mobile phase, column selection, and detector type. This article aims to discuss the processes involved in method development, optimization, and validation. The development and validation of analytical methods are critical in the discovery, development, and manufacturing of pharmaceutical drugs, as well as in

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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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Strasters, J. K. "Computerized method development for HPLC." TrAC Trends in Analytical Chemistry 10, no. 3 (1991): x—xi. http://dx.doi.org/10.1016/0165-9936(91)85084-5.

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K., Nagaraju, Mekala Sunil, Anusha M., Gopaiah Kurra Venkata, and Subbarao G. "Carvedilol, Tablets Assay Method Development and Validation by UV Spectroscopy, RP-HPLC and HPTLC." Trends in Pharmaceuticals and Nanotechnology (e-ISSN: 2582-4457) 2, no. 1 (2020): 37–47. https://doi.org/10.5281/zenodo.3632225.

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<em>Aim & Objectives : </em><em>The present study describes the development of a new rapid, simple, sensitive and reproducible RP-HPLC, HPTLC, UV Spectrophotometry method for the analysis of Carvedilol that offer certain advantages in its simplicity and sensitivity and applicable in routine analysis. Material & Methods: Carvedilol is polar in nature, reverse phase chromatography has been used and assay method is developed for UV-Spectroscopy, RP-HPLC, & HPTLC   & method validation is also done. Results & Discussion: The validated method was applied for the analysi

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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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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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Amol, Amrutkar, Aher Smita, and Bachhav Rishikesh. "Development And Validation Of UV-HPLC Method For The Estimation Of Diacerein In Bulk And Tablet Dosage Form." International Journal In Pharmaceutical Sciences 1, no. 1 (2022): 94–103. https://doi.org/10.5281/zenodo.6220056.

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<strong>Objective: </strong>Objective of the present analytical research work was to develop and validate Spectrophotometric method and High Performance Liquid Chromatographic method (HPLC Method) for the Diacerein bulk and tablet dosage form <strong>Methods: </strong>A spectrophotometric method and a HPLC method have been developed and validated for estimation of Diacerein in bulk. <strong>Method A (UV SPECTROMETRY Method): </strong>Methanol was used for the preparation of stock and working standard solutions of the drugs. 400-200nm UV range was used to scanned standard solutions of drugs usi

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Madhuri, R. Shirsath Sonali A. Waghmare And Pradyumna P. Ige. "A Review On Recent Advances In Development Of RP-HPLC Method." International Journal of Pharmaceutical Sciences 2, no. 8 (2024): 2674–82. https://doi.org/10.5281/zenodo.13242715.

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The development and validation of analytical methods play crucial roles in drug discovery, drug development, and the production of different pharmaceutical formulations. A straightforward, accurate, exact, and targeted RP-HPLC approach was created to determine the drug in pharmaceuticals. Because of its greater selectivity and flexibility for hydrophobic substances, reverse-phase liquid chromatography (RP-HPLC) is the separation method of choice for high-performance liquid chromatography (HPLC). The development of RP HPLC methods has advanced significantly in recent years, with new stationary

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Mutton, I. M. "“Practical HPLC method development”, 2nd edition." Chromatographia 47, no. 3-4 (1998): 234. http://dx.doi.org/10.1007/bf02466588.

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Rosano, T. G., R. T. Ambrose, A. H. Wu, T. A. Swift, and P. Yadegari. "Candidate reference method for determining creatinine in serum: method development and interlaboratory validation." Clinical Chemistry 36, no. 11 (1990): 1951–55. http://dx.doi.org/10.1093/clinchem/36.11.1951.

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Abstract We describe a "high-performance" liquid chromatographic (HPLC) method for accurately determining creatinine in serum. After prechromatographic precipitation of protein, we performed isocratic ion-exchange chromatography with ultraviolet detection (234 nm). Analytical results showed linearity up to 1770 mumol/L, a detection limit of 22 mumol/L, an average analytical recovery of 101%, and a CV ranging from 3% to 11%. We used certified human serum (National Institute of Standards and Technology), and additional lyophilized serum pools also assayed by definitive isotope-dilution mass spec

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M, Amjad. "A Comprehensive Review on HPLC Method Development, Validation, Optimization in Pharmaceuticals." Open Access Journal of Waste Management & Xenobiotics 6, no. 3 (2023): 1–9. http://dx.doi.org/10.23880/oajwx-16000188.

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The analytical method development in Pharmaceuticals is most important because it is the regulatory requirements. The determination of Active Ingredients of Pharmaceuticals (API) and Excipients is only possible when the testing method will be validated as per ICH, WHO guidelines or GMP requirements. The development will be reliable when the correct and precise strategy will be followed. Here, the systematic method development technique and validation parameters have been discussed precisely. This comprehensive review will be very helpful for analysts to develop analysis method of new molecules

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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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Sagar, N. Katke*1 Santosh P. Kumbhar2 Vinod D. Usnale3 Siddhant M. Sawant4. "The Method Development And Validation Of A High-Performance Liquid Chromatographic Method For Azilsartan Analysis." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1152–61. https://doi.org/10.5281/zenodo.11240815.

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The goal of the current study is to develop an RP-HPLC-based analytical method for determining the dosage of Azilsartan in bulk and tablet form that is fast, precise, sensitive, selective, and repeatable. Create a novel HPLC technique for Azilsartan estimation, and validate it in compliance with ICH guidelines. In order to make use of the accepted methodology for Azilsartan estimation in pharmaceutical formulations, an RP-HPLC method was utilized to create and validate a stability indicating method. Using an Inertsil-ODS C18 (250×4.6mm, 5µm) column and a 90:10 v/v methanol: acetoni

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Aditi, Gade* Prasanna Datar. "A Review on Analytical Method Development for Drug Sitagliptin." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 2713–21. https://doi.org/10.5281/zenodo.15263891.

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The Sitagliptin offer significant therapeutic benefits in managing type 2 diabetes mellitus (T2DM) and associated cardiovascular risks. The development of accurate, precise, and validated analytical methods is crucial for ensuring their efficacy, safety, and regulatory compliance. This review explores various analytical techniques, including High-Performance Liquid Chromatography (HPLC), Reverse Phase HPLC (RP- HPLC), High-Performance Thin Layer Chromatography (HPTLC), Liquid Chromatography-Mass Spectrometry (LC-MS/MS), and UV spectrophotometry, highlighting their advantages, challenges, and v

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Sabir, Azim Md, Mitra Moloy, and Parminder S. Bhasin. "HPLC METHOD DEVELOPMENT AND VALIDATION: A REVIEW." International Research Journal of Pharmacy 4, no. 4 (2016): 39–46. http://dx.doi.org/10.7897/2230-8407.04407.

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Kaliyan, Ayyavoo, Vijay D. Gangan, and Trupti Bamne. "HPLC METHOD DEVELOPMENT FOR EMBELIN ESTERS DERIVATIVES." INTERNATIONAL RESEARCH JOURNAL OF PHARMACY 5, no. 6 (2014): 508–13. http://dx.doi.org/10.7897/2230-8407.0506104.

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Saudagar, R. B., and Manisha M. Mahale. "Stability Indicating HPLC Method Development: A Review." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 1103–4. http://dx.doi.org/10.22270/jddt.v9i3-s.2965.

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High performance liquid chromatography is one of the most accurate method widely used for quantitative as well as qualitative analysis of drug product and it is used for determining drug product stability. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacturing of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Keywords: stability indicating method, high performance liquid chromatography, drug substance.

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D., Kawade*1 Aishwarya Shrirao2 Irshad Ahmad Mohd Salim3. "Comprehensive Review on Analytical Method Development and Validation: Focus on HPLC Techniques." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 1444–58. https://doi.org/10.5281/zenodo.14883977.

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High Performance thin-layer liquid chromatography refers to a feasible, sophisticated analytical method established upon thin-layer chromatography (TLC) concepts that offers several important advantages, including better material application, quicker and more efficient separation and lower mobile phase usage. The intent of this investigation had been to provide a quick as well as easy HPTLC approach to Piroxicam identification. The suggested technique can be applied to detect the substances under analysis at extremely low quantities. The suggested approach is straightforward, eco-friendly, sta

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Parmar, Raghuveersinh, Dr Priyanka Patil, Dr Chainesh Shah, and Dr Umesh Upadhyay. "A Review Article on Method Development and Validation of Verapamil by RP-HPLC Method." International Journal of Pharmaceutical Research and Applications 09, no. 05 (2024): 977–88. https://doi.org/10.35629/4494-0905977988.

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High performance liquid chromatography, one of the most powerful analytical techniques utilized in the separation, identification, and quantification of complex mixtures. Reverse-phase or RP-HPLC is commonly practiced in high performance liquid chromatography because this technique has the advantages of versatility and appropriateness for more hydrophobic compounds. Fundamentals and Practices of Reversed-Phase HPLC: Part II -- RPHPLC column configurations. It consists of the concept of separation, types of stationary and mobile phases with the variables concerned with the separation. This revi

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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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Vinayak, A. katekar, P. Kothari Prafful, S. Kawarkhe Swapnil, P. Surung Manish, and B. Akotkar Vaishnavi. "A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin." GSC Biological and Pharmaceutical Sciences 24, no. 1 (2023): 310–18. https://doi.org/10.5281/zenodo.8265469.

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Metformin HCl and empagliflozin are oral antidiabetic medications that help control blood sugar levels. A simple, precise, rapid, accurate, sensitive, specific, and stable RP-HPLC method was developed and validated for the simultaneous determination of Metformin and Empagliflozin in drug bulk form and drug dosage. This new RP-HPLC method is superior to formal reversed-phase HPLC with reduced solvent usage, retention time, resolution, and cost. Upper region separation was performed on a Waters HPLC system equipped with a PDA detector and autosampler. Both Metformin and Empagliflozin undergo str

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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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Jajang Japar Sodik and Rusi Rismawanti. "Method Development for Analysis of Cyclodextrin Inclusion Complexes with HPLC." International Journal of Health and Medicine 1, no. 4 (2024): 85–100. http://dx.doi.org/10.62951/ijhm.v1i4.91.

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Cyclodextrin inclusion complexes have been widely used in the pharmaceutical industry to improve drug solubility and bioavailability. Analysis of these complexes using HPLC requires the development of appropriate and validated methods. To analyze and compare various HPLC methods used for the analysis of cyclodextrin inclusion complexes, and to identify challenges and trends in method development. A literature review was conducted of articles published in the last 10 years, focusing on HPLC methods for the analysis of cyclodextrin inclusion complexes. Parameters compared included column type, m

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Vinayak A. katekar, Prafful P. Kothari, Swapnil S. Kawarkhe, Manish P. Surung, and Vaishnavi B. Akotkar. "A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin." GSC Biological and Pharmaceutical Sciences 24, no. 1 (2023): 310–18. http://dx.doi.org/10.30574/gscbps.2023.24.1.0233.

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Metformin HCl and empagliflozin are oral antidiabetic medications that help control blood sugar levels. A simple, precise, rapid, accurate, sensitive, specific, and stable RP-HPLC method was developed and validated for the simultaneous determination of Metformin and Empagliflozin in drug bulk form and drug dosage. This new RP-HPLC method is superior to formal reversed-phase HPLC with reduced solvent usage, retention time, resolution, and cost. Upper region separation was performed on a Waters HPLC system equipped with a PDA detector and autosampler. Both Metformin and Empagliflozin undergo str

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Swami, Pramod, Dilip Agrawal, Rakesh Goyal, Gaurav Bhaduka, and Mohit Khandelwal. "Method development and validation of RP-HPLC method in tablet dosage form: A Review." Pharmaceutical and Chemical Journal 9, no. 5 (2022): 48–57. https://doi.org/10.5281/zenodo.13973791.

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HPLC is the dominant separation technique for drug detection, separation and quantification. To optimize the method, a number of chromatographic parameters were analyzed, such as sample pre-treatment, selection of mobile phase, columns, detector selection. The aim of this article is to review the development, optimization and validation of the method. HPLC method development depends on the chemical structure of molecules, synthetic route, solubility, polarity, pH and pKa values and activity of functional groups, etc. Validation of HPLC method according to ICH guidelines provides information on

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Anjani, M. Nikhare* R.T. Lohiya S. W. Rangari M. J. Umekar. "A Review on Method Development and Validation." International Journal of Pharmaceutical Sciences 2, no. 11 (2024): 312–18. https://doi.org/10.5281/zenodo.14044901.

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Developing analytical methods and then validating them is a crucial step in the drug discovery process. The absence of an approved analytical technique will prevent the medicine from reaching the market, even though it has good potency. As a result, the quality and safety of the medication.  In order to assess the stability of the drugs in the presence of excipients and other stress conditions encountered during their shelf life period, this review's primary goal is to provide an overview of the traditional and innovative methods available for the analysis of drugs in their raw material a

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Sharma, Bhavik, and Sushil Kumar Agarwal. "RP-HPLC Method Development and Validation for Estimation of Acebrophylline." Asian Journal of Pharmaceutical Research and Development 6, no. 6 (2019): 66–68. http://dx.doi.org/10.22270/ajprd.v6i6.445.

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Chromatography, a separation technique, is mostly used in chemical analysis in which High-performance liquid chromatography (HPLC) is an extremely versatile technique where analytes are separated by passage through a column packed with micrometer-sized particles. Theses day reversed-phase chromatography is commonly used separation technique in HPLC. The reasons for this include the simplicity, versatility, and scope of the reversed-phase method as it is able to handle compounds of a diverse polarity and molecular mass. Reversed phase chromatography has found both analytical and preparative app

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Indira, S. Indira, K. Devi, and V. Kalvimoorthi. "Method Development and Validation of Luliconazole Bulk Drug Using Reverse Phase - HPLC Technique." Indian Journal Of Science And Technology 17, no. 39 (2024): 4094–100. http://dx.doi.org/10.17485/ijst/v17i39.2787.

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Objective: To develop and validate the RP- HPLC method for determining Luliconazole in bulk and pharmaceutical formulations. Methods: Following the International Conference on Harmonization (ICH) guidelines, a sensitive, accurate, and specific reversed-phase HPLC technique was created and validated for the detection of Luliconazole. Using high-performance liquid chromatography, this drug was examined. A better separation of the drug was achieved by using Agilent Eclipse XDB C (4.6mm x 250mm, 5µm) with a mobile phase consisting of a mixture of Acetonitrile and Buffer in HPLC water. The ratio of

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Khan, Hamid. "Analytical Method Development in Pharmaceutical Research: Steps involved in HPLC Method Development." Asian Journal of Pharmaceutical Research 7, no. 3 (2017): 203. http://dx.doi.org/10.5958/2231-5691.2017.00031.4.

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Sayali, V. Ganjiwale* A. P. Dewani A. V. Chandewar. "A Comprehensive Overview Of HPLC Method Development And Validation." International Journal in Pharmaceutical Sciences 2, no. 1 (2024): 802–11. https://doi.org/10.5281/zenodo.10581387.

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HPLC has become the workhorse of analytical separations due to its versatility, sensitivity, and precision. However, optimizing and validating an HPLC method for specific analytes requires an intricate adjustment of parameters. This review provides a comprehensive overview of the key steps involved in developing and validating a robust HPLC method. Initially, we delve into the critical factors influencing method development, including analyte properties, sample preparation strategies, column selection, mobile phase optimization, and detector choice. We detail the importance of resolution, peak

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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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Vyawhare, Puja, and Rupali Tasgaonkar. "Reversed Phase HPLC Method Development and Simultaneous Determination of Topical Dosage Form." International Journal of Science and Research (IJSR) 11, no. 8 (2022): 39–43. http://dx.doi.org/10.21275/sr22717161753.

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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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Sharma, Bhavik,, and Sushil Kumar Agarwal. "RP-HPLC Method Development and Validation for Estimation of Acebrophylline." Asian Journal of Pharmaceutical Research and Development 6, no. 6 (2019): 56–59. http://dx.doi.org/10.22270/ajprd.v6i6.446.

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Acebrophylline is an anti-inflammatory and airway mucus regulator. It had ambroxol and theophylline-7-acetic acid, the former facilitates the biosynthesis of pulmonary surfactant which raises blood levels of ambroxol, by stimulating surfactant production. Chemical structure of acebrophylline is 1, 2, 3, 6- tetrahydro-1, 3-dimethyl-2, 6-dioxo-7H-purine-7-aceticacidwithtrans-4-[(2-amino-3, 5 dibromophenyl) methyl] aminio] cyclohexanol. Survey revealed that various analytical methods like spectrophotometric, HPLC, and RP-HPLC, have been reported for the determination of Ambroxol HCl and Theophyll

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Isane, Sumit P., Santosh A. Waghmare, and Hemant V. Kamble. "A Review on Method Development, Validation, Optimization and Applications of HPLC." International Journal for Research in Applied Science and Engineering Technology 10, no. 5 (2022): 1860–67. http://dx.doi.org/10.22214/ijraset.2022.42685.

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Abstract: High-Performance Liquid Chromatography (HPLC) is a technique used to separate components from the mixture. The technology consists of two phases, the stationary phase, and the mobile phase. Component separation is based on differences in partition coefficients in two phases. The present review article focuses on the principle, types, instrumentation, process validation, application, advantages, disadvantages of HPLC. HPLC methods development and validation play important roles in the discovery, development, manufacture of pharmaceutical drugs, and various other studies related to hum

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Kishore, Venkata, V. Tejeswara Rao, D. Aditya Deepthi, and N. Annapurna. "Method Development of an Analytical Procedure for the Determination of Clofarabine in Pharmaceutical Formulations." Pharmaceutics and Pharmacology Research 4, no. 5 (2021): 01–08. http://dx.doi.org/10.31579/2693-7247/060.

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A novel, simple and economic high performance liquid chromatography (HPLC) method has been developed for the estimation of Clofarabine in bulk and tablet dosage form with greater precision and accuracy.The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Clofarabine in bulk and tablet dosage forms. All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was

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Shubham, G. Padol* Sonali A. Waghmare. "Development And Validation Of RP-HPLC Method For Estimation Of Indapamide: A Review." International Journal of Pharmaceutical Sciences 2, no. 5 (2024): 1588–97. https://doi.org/10.5281/zenodo.11355337.

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Indapamide, a thiazide-like diuretic, is widely used in the management of hypertension and edema. The accurate quantification of indapamide in pharmaceutical formulations and biological samples is crucial for ensuring its efficacy and safety. High-performance liquid chromatography (HPLC) is the preferred analytical technique for the quantification of indapamide due to its high sensitivity, selectivity, and efficiency. This review provides an overview of the development and validation of reversed-phase HPLC (RP-HPLC) methods for the estimation of indapamide in various matrices. The review discu

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KHANDARE, BALU, Atish C. Musle, Sanket S. Arole, and Pravin V. Popalghat. "Analytical method development and validation of olmutinib bulk drug as per ICH Q2 guidelines by using RP-HPLC Method." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 608–11. http://dx.doi.org/10.22270/jddt.v9i4-a.3527.

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RP-HPLC is fast, simple, sensitive, precise, and reproducible (liquid chromatography) method, developed and validated to analyseolmutinib bulk dosage form. Using C-18 HPLC column separation was carried out. This was maintained at ambient temperature. During separation mobile phase consist of methanol (100 v/v) was delivered at a rate of 1mL/min. Using UV detector analysis was carried out at the wavelength 267.68 nm. RP-HPLC method was validated by using various parameters like, precision, limit of quantitation (LOQ), linearity and robustness. The RP-HPLC method was found to be linear over the

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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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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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Varade, Priyanka R., Mahavir G. Narwade, and Varsha N. Tambe. "Method Development and Validation of Irbesartan by RP-HPLC Method." Research Journal of Science and Technology 12, no. 2 (2020): 131. http://dx.doi.org/10.5958/2349-2988.2020.00016.9.

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Divya, Bhondve* Rasika Kamthe Samruddhi Zagade Biradar S. M. "HPTLC Method Development and Validation: An Overview." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 216–22. https://doi.org/10.5281/zenodo.14264166.

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This review composition gives knowledge of about HPTLC- grounded logical system development and confirmation parameter in agreement to practical evaluation. It meets norms and minimizes crimes and disquisition. This review composition helps to choose stylish mobile phase and gives guidelines for the good confirmation practice and understand the way of logical procedure. High- Performance Thin Subcaste Chromatography (HPTLC) is an enhanced and automated system of thin- subcaste chromatography TLC) that offers superior separation performance and discovery limits and is constantly a great cover f

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Bollepaka, Srilatha Santhosh Illendula. "STABILITY INDICATING METHOD DEVELOPMENT OF RIMONABANT AND IT's VALIDATION BY RP-HPLC AND HPTLC METHOD." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 06 (2018): 5602–10. https://doi.org/10.5281/zenodo.1297120.

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A new simple, accurate, rapid, precise, reproducible and cost effective HPLC and HPTLC method for the quantitative estimation of Rimonabant in bulk and pharmaceutical dosage form. In Method using HPTLC, chromatograms were developed in a mobile phase of 2 mM Sodium dihydrogen orthophosphate (NaH2PO4)-Acetonitrile (38:62) for approximately 25 mins and detected at λmax of 303 nm. Accuracy was found to be in the range of 98.31-102.25 % whereas intraday precision was found to be in the range of 0.03 to 1.60%. Interday precision was found to be 1.36, 0.74 and 0.31 at LQC, MQC and HQC, respect

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Patel, Bhoomi D., Tanvi A. Nayak, and Saiyad Aaftab Hussain Tajmmul Hussain. "Development of RP-HPLC Method of Tizanidine HCL with Some Validation Parameter." Chinese Journal of Applied Physiology 40 (2024): e20240007. http://dx.doi.org/10.62958/j.cjap.2024.007.

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This study compiles the information for the development of analytical methods for estimation of the Tizanidine HCl that will be helpful for further research work on this drug and its impurity. The present Literature survey provides information about the Analytical methods like UV,TLC,RP-HPLC,HPTLC,UHPLC and other methods have been reported for Tizanidine HCl drug individually and along with other drugs. The analysis of published data revealed that, there was only UV spectroscopic method (calibration curve metod) is reported for estimation of Tizanidine HCl fixed dose combination. Estimation of

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Rarokar, Nilesh R., and Pramod B. Khedekar. "Stability indicating RP-HPLC method development for docetaxel trihydrate." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 525–28. http://dx.doi.org/10.22270/jddt.v9i4-s.3362.

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The purpose of present study was to develop RP-HPLC method for estimation of docetaxel trihydrate which should be a suitable, simple, precise, accurate, robust, and reproducible. The samples were assayed by the Shimadzu HPLC instrument - LC-20AD (Japan) equipped with Shimadzu SPD-M20A UV-VIS detector operated at wavelength of 230 nm. The binary gradiant pump was used for the analytical method development. The reverse phase stainless steel column (150 × 4.6 mm) packed with 5 μm particles (C-8, LiCrosphore® 100, Germany) was used to take chromatograph. A mobile phase consisting of acetonitrile/p

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