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Journal articles 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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1

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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9

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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Nerkar, Amit G., and Yash Patil. "A comprehensive review of analytical strategies for validating RP-HPLC methods of aceclofenac and thiocolchicoside in bulk drug and formulation." Current Trends in Pharmacy and Pharmaceutical Chemistry 6, no. 3 (2024): 84–95. http://dx.doi.org/10.18231/j.ctppc.2024.022.

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This comprehensive review explores the analytical method development and validation of Aceclofenac and Thiocolchicoside bulk drugs and formulations using Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). Aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), and Thiocolchicoside, a muscle relaxant, are commonly co-formulated for the treatment of pain and inflammation. The review discusses the principles and strategies involved in RP-HPLC method development, emphasizing factors such as stationary phase selection, mobile phase composition, and detection wavelength optimization

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Vinyas, M., Swapna Velivela, Gopi Yadav, Nikunja B. Pati, and VRM Gupta. "Analytical Method Development and Validation of Alogliptin by RP-HPLC Method." Research Journal of Pharmacy and Technology 9, no. 7 (2016): 775. http://dx.doi.org/10.5958/0974-360x.2016.00148.7.

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Shanmugasundaram, P. "Analytical method development and validation of Lumefantrine by RP-HPLC." African Journal of Biological Sciences 6, no. 3 (2024): 399–406. http://dx.doi.org/10.48047/afjbs.6.3.2024.399-406.

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A reversed-phase high-performance liquid chromatography (RP-HPLC) utilizing a Waters Symmetry column (150 x 3.9mm, 5µm) emerged as a reliable and straightforward approach for accurately estimating and validating Lumefantrine assay.

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Madhusudhan, Merugu, and Darshanam Vijaykumar. "Analytical Method Development and Validation of Nicardipine by RP-HPLC." Journal of Pharma Insights and Research 2, no. 1 (2024): 150–56. https://doi.org/10.5281/zenodo.10636661.

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Vaishnavi, Kale Swati Pandey* Prem Samundre Jitendra Banweer. "The Role of Quality by Design (QbD) in the Development and Validation of Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) Methods." International Journal of Pharmaceutical Sciences 3, no. 1 (2025): 411–15. https://doi.org/10.5281/zenodo.14619592.

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Quality by Design (QbD) is an organized, scientific approach to pharmaceutical development that focuses on embedding quality into products and processes from the very beginning. In the context of Reverse Phase High-Performance Liquid Chromatography (RP-HPLC), QbD provides a solid framework for developing and validating methods, ensuring their reliability, reproducibility, and consistency. This review examines the integration of QbD principles in the development and validation of RP-HPLC methods, highlighting key aspects such as the Analytical Target Profile (ATP), risk assessment, Design of Ex

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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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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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Kavana D C and Naveen Kumar G S. "Recent Progress in Analytical Method Development and Validation of Dapagliflozin." Journal of Pharma Insights and Research 3, no. 2 (2025): 090–97. https://doi.org/10.69613/046d6z97.

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Recent advances in analytical methodology for dapagliflozin quantification have highlighted various instrumental approaches crucial for pharmaceutical quality control. Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, requires precise analytical methods for its determination in pharmaceutical formulations. Multiple validated techniques including UV spectrophotometry, reversed-phase high-performance liquid chromatography (RP-HPLC), and high-performance thin-layer chromatography (HPTLC) have emerged for analyzing dapagliflozin alone and in combination with other antidiabetic agents. UV

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Nikam, Mr Nilesh, Dr Avish Maru, and Dr Anil Jadhav Dr Prashant Malpure. "Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines." International Journal of Trend in Scientific Research and Development Volume-3, Issue-3 (2019): 415–19. http://dx.doi.org/10.31142/ijtsrd22812.

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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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Y., Naveen Kumar, Divya B., and J. Sreekanth Dr. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ELBASVIR BY USING RP-HPLC." Journal of Pharma Research 7, no. 12 (2018): 342–48. https://doi.org/10.5281/zenodo.14227211.

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<strong>Abstract</strong> <strong>A</strong> rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Elbasvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Zorbax C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Phosphate Buffer pH 3.9 (55:45v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 255nm. The retention time of the Elbasvirwas 2.061 ±0.02min. The method produce linear responses in the concentration range of 1-5µg/ml o

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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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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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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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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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P., Hari Sravanth Reddy *. Anusha Kota Syed Muneer. "METHOD DEVELOPMENT AND VALIDATION OF NEW RPHPLC METHOD FOR THE ESTIMATION OF PAROXETINE IN PHARMACEUTICAL DOSAGE FORM." Indo American Journal of Pharmaceutical Sciences 04, no. 07 (2017): 2151–63. https://doi.org/10.5281/zenodo.837292.

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Present study aims to develop rapid, greater sensitivity and faster elution by RP-HPLC method for the estimation of Paroxetine. The developed method will be validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The scope of developing and validating analytical methods is to ensure suitable methods for a particular analyte of more specific, accurate, precise and robust. The main objective for this is to improve the conditions and parameters, which should be followed in the development and validat

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Vaishnav lal C L, Chandan R S, Maruthi R, and Gurupadayya B M. "Analytical and Bio-Analytical Method Development and Validation of Dichlorvos Pesticide Using RP-HPLC Method." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 5650–58. http://dx.doi.org/10.26452/ijrps.v11i4.3205.

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Organophosphorus compounds were synthesised in the 1800s. Later they are used as insecticides in the late 1930s and early 1940s. The German scientist Gerhard Schrader is known for the creation of the basic chemical structure of anticholinesterase organophosphate compounds and development of the first commercialised Organophosperous insecticide. Such chemicals are anticholinesterase insecticide commonly used in agriculture and horticulture. To a lesser extent, they are used for domestic use. Due to the absence of bio persistence in organophosphates, most of the western countries opted to substi

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Madhukar., A. *. Y. Ganesh Kumar2 K. Usha M. Srilatha. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FELODIPINE IN BULK AND TABLET DOSAGE FORM BY USING RP-HPLC TECHNIQUES." Indo American Journal of Pharmaceutical Sciences 04, no. 09 (2017): 3248–53. https://doi.org/10.5281/zenodo.987841.

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This paper describes the analytical method suitable for validation of Felodipine by reversed Phase High Performance Liquid Chromatography (RP-HPLC) method. The method utilized RP-HPLC (Water 2695 with PDA detector) model and a column ODS C18 (4.6 x 150mm, 5m). The mobile phases were comprised with Acetonitrile and Water (80:20 V/V) at a flow rate of 1.0 ml/min. UV detection at 305 nm MTS were eluted with retention times of 3.155min. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable, and reprodu

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Mohammed, Idrees H.* Sunitha P. G. Deattu N. Jawaharsamuvel R. "Rupatadine: A Review On Analytical Method Development And Validation For Quantification Of Bulk And Pharmaceutical Dosage Form By Liquid Chromatography." International Journal of Pharmaceutical Sciences 2, no. 11 (2024): 15–26. https://doi.org/10.5281/zenodo.14024347.

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Through its interaction with certain receptors, rupatadine, a non-sedative, selective, and long-acting H1 antihistamine, has antagonistic PAF effects. We have conducted a thorough literature review of numerous journals pertaining to analytical and pharmaceutical chemistry. Additionally, we have examined instrumental analytical methods developed and employed for the purpose of identifying drugs in bulk pharmaceuticals, formulations, and biological fluids, either individually or in combination with other drugs. The most recent analytical techniques, such as liquid chromatography, RP HPLC, HPTLC,

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Zinjad, Sanchay S., S. G. Patel, D. D. Gaikwad, and S. L. Jadhav. "Analytical Method Development of Saxagliptin HCl by RP-HPLC." Journal of Drug Delivery and Therapeutics 9, no. 4 (2019): 274–78. http://dx.doi.org/10.22270/jddt.v9i4.3040.

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Reversed-phase chromatography is the mainly used in chromatographic mode, it is used to separate neutral molecules in solution based on their hydrophobicity. This technique is the reverse of normal-phase chromatography in the intelligence that it involves the employ of a polar mobile phase and a non-polar stationary phase. A sensitive, accurate, rapid, cost effective and robust HPLC method was developed for the quantification of Saxagliptin Hydrochloride (SGH) with UV detector. In this method, a reversed-phase Grace C18 (250mm x 4.6ID, Particle size: 5 micron) column with a mobile phase of met

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Rameshpetchi, Rajendran Devikasubramaniyan* Ramya Sri Sura M. Deepthishalini K. Sirisha K. Janaiah K. Kaveri L. Jyothi. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF ZALEPLON IN PURE AND TABLET FORMULATION." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2103–9. https://doi.org/10.5281/zenodo.1214544.

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A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Zaleplon in its pure form as well as in tablet dosage form. Chromatography was carried out on XBridge C18 (4.6×150mm, 5µ) column using a mixture of Methanol (100%v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 253nm. The retention time of the Zaleplon was 2.4 ±0.02min. The method produce linear responses in the concentration range of 25-120µg/ml of Zaleplon. The method precision for the determination of assay wa

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Dipak, R. Borase* Vilas. L. Badgujar Nitin. L. Shirole Charushila P. Ahire Harshada Pawara. "Analytical Method Development, Validation Of Pitolisant Drug By Using RP-HPLC Method." International Journal in Pharmaceutical Sciences 2, no. 8 (2024): 2784–93. https://doi.org/10.5281/zenodo.13273666.

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Attempts to develop a robust RP-HPLC method for estimating Pitolisant in tablet form were made using an Agilent (S.K) Gradient System with a UV Detector. The C18 column employed measured 250 mm x 4.6 mm with a particle size of 5 μm. The mobile phase consisted of methanol and 0.1% water with OPA in a 45%:55% v/v ratio. Detection was carried out at a wavelength of 266 nm with a flow rate of 0.8 ml/min. The retention times for Pitolisant were found to be 3.934 and 4.627 minutes. The method was validated in accordance with ICH guidelines, demonstrating linearity over the range of 5-25 μg/ml,

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AMALA SADHE, KRUTHIVENTI. SAI PRIYANKA, and AKISHINTALA SREE GAYATRI. "Method development and validation of ornidazole by using RP-HPLC." International Journal of Science and Research Archive 13, no. 2 (2024): 2015–22. https://doi.org/10.30574/ijsra.2024.13.2.2353.

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Analytical way is more suitable, highly precise, safe and selective. Developing analytical method for newly introduced pharmaceutical formulation is a matter of most importance. The technique which is widely used to check the quality of drug is known as ‘CHROMATOGRAPHY’. Our present plan is to develop a new, simple, precise or accurate method for analysis of ORNIDAZOLE formulation after a detailed study a new RP-HPLC method was decided to be developed and validated. Ornidazole is a popular anti-protozoal agent. Different concentrations of drug solutions are prepared for method validation. Inje

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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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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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Tyagi, Ishu, Kandasamy Nagarajan, and Snigdha Bhardwaj. "Analytical Method Development and Validation of Efavirenz by Using RP- HPLC." International Journal of Pharmaceutical Investigation 15, no. 1 (2024): 159–69. https://doi.org/10.5530/ijpi.20251789.

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Shaikh, Zaheer, Om Gadhave, Bhavesh Salunke, et al. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR TRETINOIN ESTIMATION." RASAYAN Journal of Chemistry 18, no. 02 (2025): 981–88. https://doi.org/10.31788/rjc.2025.1829240.

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A straightforward, sensitive, and verified (RP-HPLC) technique was created to estimate the amount of retinoin in topical formulations. A Cosmosil C18 column with a mobile phase made up of methanol and water at a 90:05 (v by v) ratio is used to accomplish chromatographic separation. Detection is conducted at 356 nanometers, and the flow rate is retained constant in 1.0 mL/min. The correlation coefficient (R2) was nearly 1, and the method showed excellent linearity in the concentration range 5–25 µg/mL. High sensitivity is indicated by the determined limits of detection and quantification, which

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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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Mr., Rahul M. Sagde, Pawan N. Karwa Mr., Vivek M. Thorat Mr., and S. Jadhav Sanjay. "Analytical Method Development and Validation for the Estimation of Zolmitriptan by RP HPLC Method." International Journal of Trend in Scientific Research and Development 3, no. 5 (2019): 804–10. https://doi.org/10.5281/zenodo.3589767.

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In this work the authors have proposed a simple, specific, economic and accurate reverse phase liquid chromatographic method for the estimation of Zolmitriptan as an active pharmaceutical ingredient and in pharmaceutical formulation. The main objective of the current research paper is to To develop simple, precise and accurate RP HPLC method for Zolmitriptan also to validate the developed method as per ICH guideline Q2R1 and to explore the applicability of the method in finished product formulation for estimation of Zolmitriptan during its lifecycle. The objective was achieved by optimized con

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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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K. Pooja, S. Marakatham, and B. Raj Kamal. "Analytical Method Development and Validation of Cephalexin and Carbocisteine by RP-HPLC." International Journal of Enhanced Research In Science Technology & Engineering 12, no. 10 (2023): 54–61. http://dx.doi.org/10.55948/ijerste.2023.1009.

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Carbocisteineand Cephalexin were measured and quantified using a quick, sensitive, and precise RP-HPLC approach that was designed and validated using the Waters HPLC System with PDA detection. Chromatography was performed using a mobile step of filtered, mixed, degassed Methanol: Water (30:70) on a column of Inertsil-ODS C18 (250 x 4.6 mm, 5) at a flow rate of 1.0 ml/min. In addition to being tested for quantification and detection limits, the system was also examined for linearity, precision, accuracy, and specificity.

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Vidhate, Sagar Ramdas, Vaibhavi Vasant Kunjir, and Rajkumar V. Shete. "Method development and validation of Sofosbuvir and iedipasvirin by HPLC: A Review." Journal of Drug Delivery and Therapeutics 9, no. 3 (2019): 745–48. http://dx.doi.org/10.22270/jddt.v9i3.2726.

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The aim of this review article is emphasizing on development and validation protocol which will used to develop and validate accurate, simple, selective and specific spectrophotometric methods for the determination of Sofosbuvir (SOF) and Ledipasvir (LDV) in pure and in their dosage forms. Thus it is necessary to develop methods for analysis with the help of number of analytical techniques which are available for the estimation of the drugs in combination. The analyst were determine the Specific, accurate, simple, selective and stability-indicating RP-HPLC method is developed and validated for

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Rahman, Zubaidur, Vijey Aanandhi M, and Sumithra M. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HYDROCHLORIDE USING RAPID HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC TECHNIQUE." Asian Journal of Pharmaceutical and Clinical Research 11, no. 11 (2018): 118. http://dx.doi.org/10.22159/ajpcr.2018.v11i11.27204.

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Objective: A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of atomoxetine HCl (ATH) in bulk and formulations.Methods: The chromatographic development was carried out on RP-HPLC. The column used as Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size), with mobile phase consisting of methanol: water 80:20 V/V. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm.Results: The retention time was found to be 5.350 min. The method was validated as per International Conference on

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Y., Naveen Kumar, Divya B., and J. Sreekanth Dr. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ZIDOVUDINE TABLET DOSAGE FORM BY RP-HPLC." Journal of Pharma Research 7, no. 12 (2018): 338–41. https://doi.org/10.5281/zenodo.14227193.

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<strong>Abstract</strong> <strong>A</strong>n accurate and precise HPLC method was developed for the Simultaneous determination of Zidovudine. Separation of the drug was achieved on a reverse phase hypersil BDS C18, 100 X 4.6 mm, 5µ using a mobile phase consisting of Buffer and acetonitril in the ratio of 65:35v/v. The flow rate was 1mL/min and the detection wavelength was 270nm. The linearity was observed in the range of 25% to 150% with a correlation coefficient of not less than 0.998. The %RSD of Zidovudinein precision was found to be 0.20, 0.05 respectively. The recovery was found to

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Prapulla, Putta. "Analytical Methods Development and Validation of Naproxen and Sumatriptan by RP HPLC." International Journal of Trend in Scientific Research and Development 3, no. 4 (2019): 325–27. https://doi.org/10.31142/ijtsrd23582.

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Aim and objective A simple, prÃ©cised, accurate method was developed for the estimation of Crizotinib by RP HPLC technique. Chromatographic conditions used are stationary phase BDS 250x4.6 mm, 5µ. Mobile phase buffer Methodology Acetonitrile in the ratio of 60 40 and flow rate was maintained at1ml min, detection wave length was 267 nm, column temperature was set to 30o C and diluents was methanol water System suitability parameters were studied by injecting the standard five times and results were well 50 50 , Results and Discussion Conditions were finalized as optimized meth

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Archana, B. Chavhan* Vijay S. Borkar. "Analytical Method Development and Validation for Lopinavir and Ritonavir in Bulk and Dosage Form." Int. J. in Pharm. Sci. 1, no. 8 (2023): 111–17. https://doi.org/10.5281/zenodo.8247500.

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Objective: A simple, accurate and precise RP-HPLC method for simultaneous determination of Lopinavir and Ritonavir in bulk and dosage forms. Methods: A reversed phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of lopinavir (LPV) and ritonavir (RTV) on Agilent C18 (2) 250 × 4.6 mm, 5 μ column as a stationary phase and mobile phase composition of Acetonitrile: 0.1% Ortho-phosphoric acid (pH 3.5) (80:20, v/v) at a flow rate of 1ml/min. Results: Quantification was achieved with UV detection at 217 nm. The retenti

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Rakesh, Kumar Sahu, Gupta Abhishek, Prajapati Abhishek, Tiwari Shivam, Kumar Sonu, and Tiwari Vinay. "A Review on Analytical Method Development and Validation by Using Rp-HPLC." Pharmaceutical and Chemical Journal 12, no. 2 (2025): 47–53. https://doi.org/10.5281/zenodo.15606712.

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Chromatography is primarily a separation technique, but it is primarily used in chemical analysis. High-performance liquid chromatography (HPLC) is a highly versatile technique that separates analytes by passing them through a column packed with micron-sized particles. Today, reversed-phase chromatography is the most commonly used separation technique in HPLC. Reversed-phase chromatography is used for both analytical and preparative applications in the field of biochemical separation and purification. Moderately hydrophobic molecules such as proteins, peptides and nucleic acids can be separate

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Saini, Geetanjali, Bhupendra Singh, Manish Vyas, Sumit Durgapal, Naresh Rangra, and Ashish Suttee. "RP-HPLC method development and validation of Albendazole and its impurity." BIO Web of Conferences 86 (2024): 01046. http://dx.doi.org/10.1051/bioconf/20248601046.

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Oxibendazole is a type of benzimidazole that is commonly used as an antiparasitic medication for both humans and animals. However, it is also a significant impurity found in albendazole, and it is crucial to follow the ICH Q3B criteria when analysing oxibendazole impurities. Therefore, it is recommended to use a simple, fast, sensitive, and precise RP-HPLC approach to identify oxibendazole impurities in bulk and pharmaceutical formulations of albendazole.To separate the oxibendazole impurity, acetonitrile and 10 nM potassium phosphate were used as a mobile phase. Orthophosphoric acid was used

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Ritika, Todkar* Mahesh Kshirsagar Gaffar Sayyed Sanjay Garje. "Development And Validation of Rp-HPLC Method by Using Amlodipine Besylate." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4043–54. https://doi.org/10.5281/zenodo.15505690.

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A rapid, precise, and accurate Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of the anti-hypertensive drug Amlodipine. The method was optimized using a suitable mobile phase, column, flow rate, and detection wavelength to ensure effective separation and quantification. Various analytical parameters, including system suitability, linearity, accuracy, precision, robustness, and limit of detection (LOD) & limit of quantification (LOQ), were evaluated as per ICH guidelines. The method demonstrated excellent

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goswami, Sonia, Nagarajan k., richa goel, et al. "Analytical Method Development And Validation Parameters Of Drug Ivermectin." International Journal of Pharma and Bio Sciences 12, no. 1 (2022): 1–12. http://dx.doi.org/10.22376/ijpbs/lpr.2022.12.1.p1-12.

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An accurate, easy, detailed, selective and fast RP-HPLC stability representative technique was developed and validated for assessment of ivermectin in tablet dosage form. The Reverse Phase High Performance Liquid Chromatographic technique was developed for routine quantification of ivermectin in laboratory prepared mixtures as well as in combined dosage forms. The chromatographic separation was accomplished with INERTSIL C-18 ODS 250×4.6mm, 5µm particle size column along with acetonitrile and methanol as the mobile phase at a flow rate of 1ml/min. Quantification was completed by using a UV det

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