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Journal articles on the topic 'RP-HPLC Techniques for Stability Testing'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Abhijit, Pawane* Dr. Vishwas Bhagat Dr. Deepak Kardile M. M. Karne Dr. Rajkumar Shete. "A Review on RP-HPLC Techniques for Stability Testing in Drug Formulations." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3474–97. https://doi.org/10.5281/zenodo.15476001.

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RP-HPLC is one advanced analytical technique, usually for&ensp;drug analysis, can make separation, identification and quantification of drug compounds. The wide range of analyzable compounds and its adaptability to a variety of&ensp;detection methods makes it especially useful for the stability testing of a drug formulation. The purpose of stability&ensp;testing in drug development is to promote the safety, efficacy and quality of the drug product during its shelf life. RP-HPLC is one of the methods that is widely used because of its higher&ensp;resolution, greater sensitivity, specificity, an

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2

Swapnil, Khopade* Dr. Deepak Kardile Aniket Mohite Dr. Vishwas Bhagat Tushar Shinde Dr. Rajkumar Shete Vaibhavi Kunjir. "The Role of Stability-Indicating RP-HPLC In Ensuring Drug Product Quality and Shelf Life." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 3509–31. https://doi.org/10.5281/zenodo.15115168.

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Reverse-phase high-performance liquid&ensp;chromatography (RP-HPLC) is commonly employed in pharmaceutical analysis for the isolation and quantification of drugs, impurities, and degradation products. Ensuring the quality of drug products and the shelf life—determined by the potency, safety, and efficacy of a particular drug—is an important assessment that is carried out through stability studies, where environmental variables such&ensp;as temperature, humidity, and storage conditions are tested to see how they affect the drug over time. Stability-indicating RP-HPLC method is one o

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3

Jain, Neha, Amol Kakde, and Mohan Lal Kori. "Simultaneous Method Development for Pseudoephedrine Hydrochloride and Desloratadine." Journal of Drug Delivery and Therapeutics 15, no. 6 (2025): 6–13. https://doi.org/10.22270/jddt.v15i6.7157.

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Introduction: Chromatographic techniques are primarily used for the qualitative and quantitative analysis of pharmaceutical compounds, drug formulations, and raw materials throughout the drug development process, from the early research phase to the final release of therapeutic products. Objective: Simple, accurate, economical and reproducible RP-HPLC method for simultaneous estimation of two component drug mixture pseudoephedrine hydrochloride and desloratadine in combined tablet dosage form. Material and methods: Developed HPLC method is reversed phase chromatographic method using inertsil C

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Shrivas, Narayan, and S. K. Mishra. "Development and Validation of a Stability-Indicating HPLC Technique for Measuring Temozolomide in its Pharmaceutical Dose Form." Oriental Journal Of Chemistry 37, no. 4 (2021): 900–904. http://dx.doi.org/10.13005/ojc/370418.

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Using RP-HPLC, an accurate and precise technique for the measurement of Temozolomide in its pharmaceutical dose form was developed and validated. Chromatographic separation was achieved on an X Terra RP 18(250mm x 4.6mm), 5 µ column using a mobile phase consisting of methanol and buffer in the ratio of 10:990v/v. The flow rate was 1mL/min with the detection wavelength of 254 nm and retention time was found to be 20 min. The developed method was validated according to ICH guidelines. With a correlation coefficient of 0.9990, linearity was observed in the range of 50-150 percent. The %RSD of the

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5

Somase, Kanchan, and Dinesh Rishipathak. "Finerenone API Estimation Using RP-HPLC Technique and LC-MS Characterization of its Degradation Products." Oriental Journal Of Chemistry 41, no. 2 (2025): 528–40. https://doi.org/10.13005/ojc/410222.

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Researchers developed an RP-HPLC method to measure finerenone (FIN) which exhibits specificity, accuracy, precision and sensitivity. The RP-HPLC instrument functioned through an Isocratic method using a 250 mm X 4.6 mm i.d., 5μm i.d. Phenomenex C18 reversed-phase column as its component. At 252 nm wavelength the detector selected Acetonitrile: water (50:50 v/v) for operation in its analytical procedures using the mobile phase. The programmed mobile phase moved at 1mL/min through the system. The time for FIN to retain in the system under examination amounting to 4.62. Between 80–120 μg/mL conce

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Sumit, Wakchaure* Sonali Waghmare Pradyumna Ige. "A Review Analytical Advances and Challenges in Quality Control Techniques for Corticosteroid Ophthalmic Suspensions." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 1261–69. https://doi.org/10.5281/zenodo.14365890.

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Ophthalmic suspensions, particularly corticosteroid formulations, require stringent quality control (QC) measures to ensure their stability, therapeutic efficacy, and safety for patient use. Key physicochemical parameters, such as viscosity, rheological properties, pH, and osmolality, are vital in maintaining the desired characteristics of the suspension. Particle size distribution (PSD) is particularly critical, influencing both the stability and bioavailability of the active pharmaceutical ingredient (API). In addition, chemical parameters such as the assay of the API using High-Performance

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Kalyani, Ashok Patil*1 Shailesh B. Patil2. "To Develop And Validate Stability Indicating Assay Of Diloxanide Furoate By Using UV And HPLC And HPTLC Method For Pharmaceutical Dosage Form." International Journal in Pharmaceutical Sciences 2, no. 6 (2024): 498–517. https://doi.org/10.5281/zenodo.11543189.

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The study aimed to establish stability assays for Diloxanide Furoate using both High-Performance Liquid Chromatography (HPLC) and High-Performance Thin-Layer Chromatography (HPTLC) methods, covering crucial aspects of method development and validation. Detailed specifications were provided for the HPLC and HPTLC systems to ensure proper setup and functioning. Chromatographic conditions were optimized, including parameters like stationary phase, mobile phase composition, flow rate, and detection wavelength, to achieve optimal separation and detection of Diloxanide Furoate. The identity of pure

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Jeličić, Mario-Livio, Edvin Brusač, Daniela Amidžić Klarić, Biljana Nigović, Sabina Keser, and Ana Mornar. "Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques." Pharmaceuticals 13, no. 8 (2020): 187. http://dx.doi.org/10.3390/ph13080187.

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Inflammatory bowel disease is a common name for Crohn’s disease and ulcerative colitis. These inflammatory states cause damage in the sidewalls of the gastrointestinal tract, resulting in malabsorption of food and vitamins. Folic acid (Vitamin B9) is often associated with inflammatory bowel diseases since reduced overall folate concentration in the human body may lead to the development of colorectal cancer and megaloblastic anaemia. However, its deficiency is easily compensated by taking an additional folic acid pill during regular therapy. At the moment, there are no studies that have examin

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Collie, Jake T. B., Ronda F. Greaves, Oliver A. H. Jones, Glenn Eastwood, and Rinaldo Bellomo. "Vitamin C measurement in critical illness: challenges, methodologies and quality improvements." Clinical Chemistry and Laboratory Medicine (CCLM) 58, no. 4 (2020): 460–70. http://dx.doi.org/10.1515/cclm-2019-0912.

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AbstractBackgroundThere is renewed interest in high-dose vitamin C interventions in clinical medicine due to its antioxidant properties, safe use and cost-effectiveness. Yet, randomised control trials (RCTs) employing these interventions are failing to include robust analytical methodology and proper sample handling and processing techniques. Consequently, comparisons between studies becomes impossible as there is no metrological traceability and results may be prone to pre-analytical errors.ContentThrough published vitamin C stability studies, method comparison papers and data from vitamin C

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Bhanja, Mrutyunjaya, and Aayush Vaishnaw. "Development and validation of a pediatric dosage form for a commonly used medication." Journal of Neonatal Surgery 14, no. 1S (2025): 72–78. https://doi.org/10.52783/jns.v14.1498.

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Pediatric children often have difficulty administering their drugs due to a lack of age-appropriate dosage forms, which can result in inadequate therapeutic effects and poor compliance. The creation and validation of a pediatric dosage form for the regularly administered medications acetaminophen and ibuprofen for feverish conditions is the main focus of this study. By creating a kid-friendly dosage form, the study sought to address important formulation issues such as dose accuracy, taste acceptability, and excipient safety. Using a methodical approach, formulations such liquid suspensions an

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11

Yu, Congcong, Ruihan Long, Feng Cao, Xinying Zhao, Tao Lan, and Dunming Xu. "Development of Pure Certified Reference Material of Cannabidiol." Molecules 29, no. 5 (2024): 921. http://dx.doi.org/10.3390/molecules29050921.

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Cannabidiol (CBD) is the major functional component in hemp and has a broad range of pharmacological applications, such as analgesic, anti-epileptic, anti-anxiety, etc. Currently, CBD is widely used in pharmaceuticals, cosmetics, and food. To ensure the quality and safety of the products containing CBD, more and more related sample testing is being conducted, and the demand for CBD-certified reference material (CRM) has also sharply increased. However, there is currently a lack of relevant reference materials. In this paper, a simple method for preparing CBD CRM was established based on prepar

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Burle, Gowri Sankararao, Praneeth Rao Kakullamarri, Suresh Babu Kothamasu, Sudha Divya Madhuri Kallam, and Anoop Bodapati. "Case Study on Regulatory Approaches for New Degradation Impurity Exceeding ICH Thresholds in Solubilized Ibuprofen Capsules During Stability Testing." Journal of International Research in Medical and Pharmaceutical Sciences 19, no. 3 (2024): 70–82. http://dx.doi.org/10.56557/jirmeps/2024/v19i38936.

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The article discusses the identification, isolation, characterization, and toxicology study of a new degradation impurity found in stability samples of Ibuprofen soft gelatin capsules. An unknown impurity was detected during stability analysis, reaching 0.28% level, which prompted further investigation. A preparative method was developed to isolate the impurity quickly, followed by its identification and characterization using spectroscopic techniques. The impurity, named 2,3-dihydroxxypropyl 2-(4-isobutylphenyl)propanoate, was confirmed through various analyses, including HPLC, LC-MS, NMR, an

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Dnyaneshwari, Mahale Dr. Chandrakant Suryawanshi* Dr. Rajendra Wagh. "Analytical Method Development for Determination of Salasia and Guduchi in Pharmaceutical Formulation Using." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 910–24. https://doi.org/10.5281/zenodo.15175216.

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The study focuses on the development and validation of an analytical method for the determination of Salasia and Guduchi in pharmaceutical formulations using advanced chromatographic and spectroscopic techniques. An HPLC chromatographic system was utilized with optimized parameters, including stationary phase, mobile phase composition, flow rate, and detection wavelength. Pure samples of Salasia and Guduchi in pharmaceutical formulations were procured and confirmed using UV-visible wavelength scans and FT-IR spectral analysis. Calibration curves for Salasia and Guduchi demonstrated strong line

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14

Ahuekwe, E. F., A. F. Akinyele, A. E. Benson, M. I. Oniha, and O. Oziegbe. "A Review of Fabrication Techniques and Optimization Strategies for Microbial Biosensors." IOP Conference Series: Earth and Environmental Science 1342, no. 1 (2024): 012015. http://dx.doi.org/10.1088/1755-1315/1342/1/012015.

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Abstract Challenges of stability and specificity associated with early generation sensors necessitate the fabrication and optimization of microbial biosensors. More so, the global biosensors market size currently valued at USD25.5 billion in 2021 is expected to grow at a compound annual growth rate (CAGR) of 7.5% to USD36.7 billion in 2026. Microbial biosensors are bioanalytical systems that integrate microorganisms with a physical transducer to generate signals, thus, aiding the identification of analytes. The biosensors are fabricated through a series of steps comprising microbe selection, i

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15

Harshad, Tanpure* Dr. Vishwas Bahgat Dr. Deepak Kardile Dr. Rajkumar Shete M. M. Karne. "Revolutionizing Stability-Indicating Analysis: Advanced RP-HPLC Strategies for Pharmaceutical Excellence." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4466–89. https://doi.org/10.5281/zenodo.15522235.

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Stability-indicating analysis is vital to pharmaceutical quality control for&ensp;establishing the safety, efficacy, and quality of pharmaceutical drug products until their expiration date. Reversed-phase high-performance liquid chromatography (RP-HPLC) has recently become an important tool in stability&ensp;testing because of its high selectivity, sensitivity, and robustness. Abstract/Short: This review focused on recent developments&ensp;in RP-HPLC approaches for stability-indicating analysis to emphasize their importance in pharmaceutical excellency. Abstract The principles of stability-ind

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16

Moses, Alan, Jesper Bjerrum, Morten Hach, Lars Holm Wæhrens, and Anders Dyhr Toft. "Concentrations of Intact Insulin Concurs With FDA and EMA Standards When Measured by HPLC in Different Parts of the Distribution Cold Chain." Journal of Diabetes Science and Technology 13, no. 1 (2018): 55–59. http://dx.doi.org/10.1177/1932296818783783.

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Background: The article by Carter and Heinemann raised serious concerns about the concentrations of insulin in vials being sold in US pharmacies. To study the claims made in the manuscript, we reviewed Novo Nordisk data on insulin concentration. Methods: Insulin concentrations within vials from three different sources along the distribution chain were evaluated utilizing currently accepted US Pharmacopeia methodology: (1) insulin content and stability based on production batches covering 7 years of insulin production, (2) insulin content in samples returned to Novo Nordisk over the last three

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17

Braidy, Nady, Maria D. Villalva, and Ross Grant. "NADomics: Measuring NAD+ and Related Metabolites Using Liquid Chromatography Mass Spectrometry." Life 11, no. 6 (2021): 512. http://dx.doi.org/10.3390/life11060512.

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Nicotinamide adenine dinucleotide (NAD+) and its metabolome (NADome) play important roles in preserving cellular homeostasis. Altered levels of the NADome may represent a likely indicator of poor metabolic function. Accurate measurement of the NADome is crucial for biochemical research and developing interventions for ageing and neurodegenerative diseases. In this mini review, traditional methods used to quantify various metabolites in the NADome are discussed. Owing to the auto-oxidation properties of most pyridine nucleotides and their differential chemical stability in various biological ma

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18

Vuković, Vesna, Nenad Koropanovski, Stefan Marković, Anton Kos, Milivoj Dopsaj, and Anton Umek. "Specific Test Design for the In-Depth Technique Analysis of Elite Karate Competitors with the Application of Kinematic Sensors." Applied Sciences 12, no. 16 (2022): 8048. http://dx.doi.org/10.3390/app12168048.

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Karate fighters are under constant pressure to find adequate scoring solutions in ever-changing combat conditions. Thus, technique improvement at high levels of mastery demands a novel approach to key data acquisition and in-depth analysis of more than just the impact phase in punch execution. With the aim of describing the kinematic and temporal structure of a reverse punch in the developmental phase, two wireless sensors were used for the acquisition of selected quantities in ten modalities performed by a continental and world medallist. The results show that the timeline of kinematic parame

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19

Shivatare, Rakesh, Shailesh Kewatkar, Neetin Bhutale, Vibhavari Chatur, and Harshal Tare. "A Validated IVRT Method to Evaluate Semisolid Dosage Form Containing Ximenynic Acid Using a Novel Approach." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 14, no. 01 (2024): 306–15. http://dx.doi.org/10.25258/ijddt.14.1.44.

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Purpose: Ximenynic acid (XMA) holds significant potential in the market, especially due to its widespread application in the cosmetics sector. As its various biological activities continue to be discovered, there is a sharp rise in demand for ximenynic acid. A novel analytical approach has been devised for an in-house product, comparable to the reference listed drug (Softalia, containing 30% ximenynic acid), utilized in gel formulations. This method is designed to conduct in-vitro release studies employing Franz vertical diffusion cell apparatus and analytical quantification via high-performan

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20

Satyam, Dhole* Prashant Mokate Dr. Jain P. P. "Stability-Indicating RP-HPLC Method Development and Validation for Estimation of Remdesivir in Bulk and Pharmaceutical Formulations: A Comprehensive Review." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 1158–62. https://doi.org/10.5281/zenodo.14359086.

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The development of a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for remdesivir has gained prominence in ensuring its quality and stability in bulk and pharmaceutical formulations. This review systematically evaluates existing studies on RP-HPLC method development, emphasizing critical parameters such as mobile phase optimization, stress testing under forced degradation conditions, and method validation as per International Council for Harmonisation (ICH) guidelines. It further highlights analytical challenges and future perspectives in remdesivir

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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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Janavicius, Ramunas, Dovile Matiukaite, Arturas Jakubauskas, and Laimonas Griskevicius. "Microsatellite Instability Detection by High-Resolution Melting Analysis." Clinical Chemistry 56, no. 11 (2010): 1750–57. http://dx.doi.org/10.1373/clinchem.2010.150680.

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BACKGROUND Microsatellite instability (MSI) is an important marker for screening for hereditary nonpolyposis colorectal cancer (Lynch syndrome) as well as a prognostic and predictive marker for sporadic colorectal cancer (CRC). The mononucleotide microsatellite marker panel is a well-established and superior alternative to the traditional Bethesda MSI analysis panel, and does not require testing for corresponding normal DNA. The most common MSI detection techniques—fluorescent capillary electrophoresis and denaturing HPLC (DHPLC)—both have advantages and drawbacks. A new high-resolution meltin

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Shivi, Kashyap*. "Drug Dissolution and Colour Cheque Monitoring in Acidic Dissolution of Domperidone Pellets Ip (Enteric Coated)." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3358–71. https://doi.org/10.5281/zenodo.15471925.

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Domperidone, a peripherally selective dopamine D2 receptor antagonist, is frequently prescribed for the treatment of gastrointestinal motility disorders, including nausea, vomiting, and delayed gastric emptying. Despite its therapeutic potential, its oral bioavailability remains a significant challenge due to its poor solubility and instability in acidic environments, such as the stomach. To overcome these limitations, pharmaceutical scientists have developed enteric-coated pellet formulations designed to bypass the gastric region and enable targeted release in the alkaline milieu of the small

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Olufemi, Olatoye I., Olagoke Ayeni, and Olasumbo Esther Olagoke Komolafe. "Enhancing milk safety in the USA: A holistic framework for controlling aflatoxin M1 and pathogenic c in dairy supply chains." International Journal of Multidisciplinary Research and Growth Evaluation 5, no. 6 (2025): 1495–503. https://doi.org/10.54660/.ijmrge.2024.5.6.1495-1503.

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Milk safety is a critical public health concern in the United States due to the potential presence of aflatoxin M1 and pathogenic microorganisms, such as Escherichia coli, Salmonella, and Listeria monocytogenes. These contaminants pose severe health risks, including carcinogenic effects and foodborne illnesses, while threatening consumer confidence and economic stability in the dairy industry. This review proposes a holistic approach for controlling aflatoxin M1 and microbial hazards in dairy supply chains through integrated preventive, monitoring, and intervention strategies. The framework em

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Gupta Tiruveedhi, V. L. N. Balaji, Venkateswara Rao Battula, and Kishore Babu Bonige. "Stability Indicating RP-HPLC Assessment and Stability Testing of Tazarotene and Halobetasol in Lotion Formulation." Asian Journal of Chemistry 32, no. 6 (2020): 1456–62. http://dx.doi.org/10.14233/ajchem.2020.22611.

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A novel liquid chromatographic method was established and validated for the quantification of tazarotene and halobetasol in the presence of degradation products obtained during stress conditions. The liquid chromatographic method was based on isocratic elution on Knauer Eurospher II C18 (5 μm particle size, 250 mm × 4.5 mm) column using a mobile phase consisting of methanol, acetonitrile and 0.5 mM perchloric acid (40:45:15 v/v/v) mixture at flow rate of 0.9 mL/min. Quantization of tazarotene and halobetasol was done with UV detection at 234 nm. The method validity was assessed in agreement wi

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Santosh, V. Gandhi* Madhuri S. Rathi Atul P. Chaudhari. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ONDANSETRON HYDROCHLORIDE." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 01 (2018): 584–91. https://doi.org/10.5281/zenodo.1164607.

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The aim of the present study was to develop a validated stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of Ondansetron Hydrochloride. An isocratic, RP-HPLC method was developed using HiQ Sil C8 (250 x 4.6 mm, 5 μm) column and 10 mM ammonium acetate buffer (pH 3) and methanol (60:40 v/v) as mobile phase at flow rate of 0.8 ml/min at detection wavelength of 250 nm. The retention time (RT) of drug was 12.280 ± 0.034 min . The method was validated with respect to linearity, precision, accuracy and robustness. The data of linear re

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S, Mohan Rahul, Gore Shubham, Kotame Radhika, and Tagad Rupesh. "Stability Testing of Olmesartan and Cilnidipine in Bulk and Formulations by RP-HPLC." American Journal of PharmTech Research 9, no. 6 (2019): 136–44. http://dx.doi.org/10.46624/ajptr.2019.v9.i6.010.

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Murthy Pyla, Sree Rama, Prafulla Kumar Sahu, and K. Srinivas. "Stress testing of linaclotide: Development of a validated stability-indicating RP-HPLC method." Acta Chromatographica 29, no. 2 (2017): 207–17. http://dx.doi.org/10.1556/1326.2017.29.2.05.

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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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Sivappa, Naidu Peyala* Elphine Prabahar. A. RamaRao Nadendla. "DEVELOPMENT OF A NEW VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR LEFLUNOMIDE IN BULK DRUG." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 08 (2019): 14432–38. https://doi.org/10.5281/zenodo.3361691.

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<em>A validated stability-indicating RP-HPLC method for Leflunomide (LFN) was developed by separating its degradation products on a Schimadzu C18 (250×4.6mm, 5µm) column using methanol and water in the ratio of 70:30 % v/v as the mobile phase at a flow rate of 1.0 mL/min. The method was validated in terms of specificity, linearity, accuracy, precision, detection limit, quantification limit, and robustness. Forced degradation of Leflunomide was carried out under acidic, basic, peroxide, photo and thermal conditions and the major degradation products of acidic and basic degradation.

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Gayatri, Sunil Holkar* Sonali A. Waghmare. "Development And Validation Of RP-HPLC Method For Determination Of Fimasartan In Bulk And Their Dosage Form – A Review." International Journal in Pharmaceutical Sciences 2, no. 7 (2024): 13–24. https://doi.org/10.5281/zenodo.12602482.

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Fimasartan is an angiotensin II receptor antagonist used in the treatment of hypertension. Chromatography, particularly RP-HPLC, is critical for separating and studying fimasartan and other related chemicals in pharmaceutical formulations. The development and validation of RP-HPLC techniques for fimasartan is critical to ensuring accurate and reliable quantification. Method validation includes parameters such as accuracy, precision, specificity, linearity, range, limit of detection, limit of quantification, robustness, and system suitability testing, as specified by organizations such as the I

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Dr., G. Nagaraju, Teena Lavdya, Sirisha V., and Hareesh Dara Dr. "SIMULTANEOUS ESTIMATION OF IVACAFTOR AND LUMACAFTOR IN TABLET DOSAGE FORM BY RP-HPLC METHOD." Journal of Pharma Research 11, no. 6 (2022): 85–90. https://doi.org/10.5281/zenodo.14233059.

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<strong>Abstract</strong> <strong>A</strong> simple, accurate, and precise method was developed for the simultaneous estimation of Lumacaftor and Ivacaftor in tablet dosage form. The method uses a C18 column with a mobile phase of 0.1% triethylamine in acetonitrile. The retention times of Lumacaftor and Ivacaftor were 2.269 and 3.164 minutes, respectively. The %RSD for both drugs was less than 1%, and the %recovery was 100% for both drugs. The LOD and LOQ values were 0.56 and 1.71 µg/ml for Lumacaftor, and 0.07 and 0.11 µg/ml for Ivacaftor. The method was validated according to ICH

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Diksha, Vibhute, Deshpande Anant, Komal Shinde, and Priyanka Wankhede. "Stability Indicating RP-HPLC Method for Posaconazole Assay Using QbD Approach." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1401–7. http://dx.doi.org/10.25258/ijpqa.15.3.48.

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The development and optimization of analytical techniques utilizing the quality by design methodology is essential in the pharmaceutical industry. This approach helps in the direction of identifying and optimizing critical parameters during drug development and assesses their impact on key quality attributes. A stability-indicating RP-HPLC method was developed for quantifying posaconazole in bulk and tablet forms utilizing the quality-by-design approach. The Box-Behnken design optimized buffer flow rate, organic modifier percentage, and temperature, affecting retention time, theoretical plate

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A., R. Pathade V. C. Gurumukhi S. S. Chalikwar Kanchan R. Patil. "DEVELOPMENT, VALIDATION AND STABILITY INDICATING HPLC METHOD: AN OVERVIEW." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 04 (2019): 8401–12. https://doi.org/10.5281/zenodo.2652049.

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<em>The objective of this overview is coverage of development of RP-HPLC method, its validation and evaluation of stability indicating method. .Here, short comings of reported HPLC methods with respect to</em><em> regulatory aspects was highlighted. Stability-indicating assay method (SIAM) was used to differentiate the API from its potential decomposition product. Regulatory guidance status in ICH Q1A (R2), ICH Q3B (R2), Q6A, and FDA 21 CFR section 211 requires validated stability indicating methods. Force degradation of drug is required to demonstrate the specificity when developing SIAMs. Fo

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Wani, G. P., and S. B. Jadhav. "RP-HPLC AND HPTLC STABILITY INDICATING ASSAY METHODS FOR IVERMECTIN IN BULK AND TABLET DOSAGE FORM." INDIAN DRUGS 55, no. 03 (2018): 32–42. http://dx.doi.org/10.53879/id.55.03.11143.

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Simple, rapid, precise, accurate RP-HPLC and HPTLC methods have been developed and validated for ivermectin in bulk and its marketed formulation. RP-HPLC method for drug was achieved on Grace C18 (250 mm X 4.6 ID, Particle size; 5 μ) column using mobile phase acetonitrile: 10 mM phosphate buffer (95:05 v/v) pH adjusted to 3 with o-phosphoric acid. Detection of drug was done at 245 nm. The retention time was found to be 5.83 min. HPTLC method for ivermectin was accomplished on a precoated silica gel aluminium plate 60F-254 (CAMAG Linomat 5), using toluene: methanol: glacial acetic acid (8:2:0.1

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Chaitanya Prasad, M. Krishna, G. Vidhya Sagar, and P. Sudhakar. "Stability indicating RP HPLC method for determination of levitiracetam in pharmaceutical formulation." Indian Journal of Pharmaceutical and Biological Research 1, no. 04 (2013): 45–54. http://dx.doi.org/10.30750/ijpbr.1.4.9.

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The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex_ C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 ºC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 30:10:60. Auto sampler 20 μl was used and kept at 15 ºC temperature. Analysis was done with flow rate of 1.0 ml/min at 212 nm (_ max of Levetiracetam) wavelength by using photodiode array (PDA) detector. The drug was analyzed for acid, alkal

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Peddi, Pavani, S. L. Tulasi, N. Usha Rani, and T. Raja Rajeswari. "A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF AZELNIDIPINE AND ITS IMPURITIES IN PHARMACEUTICAL FORMULATION." INDIAN DRUGS 57, no. 08 (2020): 70–76. http://dx.doi.org/10.53879/id.57.08.12061.

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A novel simple, rapid, sensitive and stability-indicating RP-HPLC method was developed and validated for the determination of azelnidipine (ALDP) and its impurities 1 and 2. Resolution of drug, its potential impurities and degradation products were achieved by RP-HPLC on was performed on Prontosil ODS C18 column (250 mm x 4.6 mm, 5µ) using a mobile phase consisting of methanol and 0.1M sodium acetate 40: 60 (v/v) at a flow rate of 1 ml/min and 231 nm of UV detector. Validation of the method was performed along with formulation analysis and forced degradation studies. The calibration curves of

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Mijatović, Vesna, Mira Zečević, and Jelena Zirojević. "Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products." Arhiv za farmaciju 73, no. 3 (2023): 216–35. http://dx.doi.org/10.5937/arhfarm73-44512.

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The goal of this study was the optimization of chromatographic conditions and validation of the isocratic RP-HPLC method for monitoring the stability of aripiprazole, identification and quantitative analysis of aripiprazole and its degradation products in tablets. In addition, robustness was tested by applying the methodology of experimental design. The forced degradation study of aripiprazole was conducted in accordance with the ICH guidelines. The stability of the active pharmaceutical substance was tested under the conditions of hydrolysis in acidic, neutral and basic environments, thermal

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Shrisunder, Nikhil, Prashant Kumar Dhakad, and Ritu Gilhotra. "Novel RP-HPLC method development and validation for precise quantification of prochlorperazine maleate in pharmaceutical dosage forms." Journal of Applied Pharmaceutical Research 13, no. 1 (2025): 112–22. https://doi.org/10.69857/joapr.v13i1.782.

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Background: Prochlorperazine Maleate, a piperazine phenothiazine derivative, exhibits strong antiemetic and antipsychotic properties. However, existing analytical methods for its quantification in pharmaceutical formulations often face limitations regarding sensitivity, specificity, and accuracy. Many conventional techniques involve extensive sample preparation and prolonged analysis times, making them less feasible for high-throughput quality control. This study developed and validated a novel, precise, and highly sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method

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Pagadipally Santhosh Kumar, Pagadipally Santhosh Kumar, PatlollaNikitha Reddy PatlollaNikitha Reddy, Nagireddy Roshitha Nagireddy Roshitha, Anumolu Durga Pani Kumar Anumolu Durga Pani Kumar, and Naraparaju Swathi Naraparaju Swathi. "A comprehensive review on analytical methods of Cabotegravir." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 1784–88. https://doi.org/10.35629/4494-100217841788.

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HIV weakens the immune system, but highly active antiretroviral therapy (HAART), including the FDA-approved Cabotegravir, has improved life expectancy for those living with HIV. However, these treatments require lifelong use and can have side effects that impact adherence. Reliable methods to detect and measure Cabotegravir in pharmaceutical formulations and biological samples are crucial for ensuring its effectiveness. Chromatographic techniques like HighPerformance Liquid Chromatography (HPLC), Reverse-Phase HPLC (RP-HPLC), UltraPerformance Liquid Chromatography (UPLC), and High-Performance

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Jawaharsamuvel, R.3* Sunitha P. G.1 Deattu N.2 Mohammed Idrees3. "Atomoxetine: A Review On Analytical Method Development And Validation For Quantification Of Bulk And Pharmaceutical Dosage Form By High Performance Liquid Chromatography." International Journal of Pharmaceutical Sciences 2, no. 10 (2024): 1298–312. https://doi.org/10.5281/zenodo.13987642.

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Atomoxetine is the efficacious drug for treating attention deficit hyperactivity disorder (ADHD) in adults and children. This drugs clinical and pharmaceutical analysis necessitates efficient analytical techniques for quality assurance, pharmacodynamics, pharmacokinetic, and stability investigations. We have reviewed in detail the literature from many journals related to analytical and pharmaceutical chemistry, and we have looked at instrumental analytical methods that were created and used to find a drug in bulk drugs, formulations, and biological fluids, either by itself or in combination wi

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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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K, Nithiyananthan, and Prasada Rao KVS. "VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GLECAPREVIR AND PIBRENTASVIR BY USING ANALYTICAL QUALITY BY DESIGN (AQBD) METHOD." International Journal of Research in Ayurveda and Pharmacy 14, no. 5 (2023): 27–36. http://dx.doi.org/10.7897/2277-4343.1405140.

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The quantitative measurement of Glecaprevir and Pibrentasvir has been created using a simple, quick, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method. It is more difficult to analyse varying amounts of pharmaceutical active medicinal ingredients in dosage forms without interferences. Therefore, the objective of the current work is to estimate Glecaprevir and Pibrentasvir simultaneously by adopting an Analytical Quality by Design (AQbD), a rotatable central composite-based technique using RP-HPLC-based method development and validation.

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Vennkata Ramana Pindi B, Sravani G, Ardhanaari M, and Karthigai Priya M. "Evaluation and authentication for metformin HCL, Glimepride, atorvastatine by using bulk HPLC pharmaceutical dosage form." International Journal of Research in Pharmaceutical Sciences 11, SPL4 (2020): 740–44. http://dx.doi.org/10.26452/ijrps.v11ispl4.4057.

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Reverse phase chromatographic techniques are used for analyzing drugs. It is advanced analytical instrumentation method used for analysis of drugs. A novel accurate, precise, simple, & selective RP- HPLC technique is established and authorized for stability representing RP – HPLC technique for simultaneous assessment of Metformin HCL, Glimepiride & Atorvastatin in bulk & pharmaceutical dosage form by RP– HPLC technique. The technique on Luna C 18, 250mm × 4.6 mm, 15 µm. Column with a mobile phase comprising of buffer and acetonitrile in ratio of (85:15 v/v) and 1.0ml/ minflow rate.

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Kiran, Ukey* Indrajeet Gonjari Pratiksha Rajguru Kajal Bansode Rugved Sathawane Jayashri Dandale. "A Comprehensive Review of RP-HPLC In Bioanalytical Method Validation and Sample Preparation." International Journal of Scientific Research and Technology 2, no. 6 (2025): 270–86. https://doi.org/10.5281/zenodo.15606059.

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Bioanalytical method development is essential for the accurate quantification of drugs and their metabolites in biological matrices such as plasma, serum, or urine Techniques like liquid-liquid extraction (LLE), solid phase extraction (SPE), and protein precipitation are commonly used to isolate analytes from complex biological samples. Among various analytical tools, HPLC is widely preferred due to its speed, specificity, accuracy, and  precision. HPLC is especially suitable for analysing low dose drugs and multicomponent formulations, making it a critical component in pharmaceutical res

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Pavani, B., C. Lavanya, M. Pradeep Kumar, and Anumalagundam Srikanth. "Development and validation of a stability indicating assay method for bosentan tablets by RP HPLC." International Journal of Clinical Pharmacokinetics and Medical Sciences 5, no. 2 (2025): 35–39. https://doi.org/10.26452/ijcpms.v5i2.762.

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A simple, sensitive, stability-indicating, and precise HPLC method has been developed and validated for the estimation of Bosentan in a commercial tablet dosage form containing 169 mg of Bosentan, with a label claim of 125 mg. The compound and its impurities were successfully separated using an isocratic method on a C18 column (X Bridge C18, 3.5 µm, 150 × 4.6 mm), with a mobile phase consisting of trifluoroacetic acid and acetonitrile (50:50, v/v). UV detection was performed at 266 nm, and the flow rate was set at 1.0 mL/min. Various validation parameters, including system suitability, specifi

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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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Jaya P. Ambhore, Vaibhav S. Adhao, Rameshwar S. Cheke, Rameshwar S. Cheke, Ritesh R. Popat, and Shital J. Gandhi. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. http://dx.doi.org/10.30574/gscbps.2021.16.1.0172.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summa

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Jaya, P. Ambhore, S. Adhao Vaibhav, S. Cheke Rameshwar, R. Popat Ritesh, and J. Gandhi Shital. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. https://doi.org/10.5281/zenodo.5168617.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summa

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Jain, Hemant K., and Archana A. Gunjal. "STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF DIMETHYL FUMARATE IN BULK AND CAPSULES." International Journal of Applied Pharmaceutics 9, no. 5 (2017): 121. http://dx.doi.org/10.22159/ijap.2017v9i5.20944.

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Objective: To develop an accurate, simple, precise and specific stability indicating RP-HPLC method for estimation of dimethyl fumarate in bulk and capsules.Methods: An Inertsil ODS (150x4.6 mm, 5µ) column and a mobile phase containing acetonitrile: potassium dihydrogen phosphate buffer pH 6.8 (50:50% v/v) was used for this study. The flow rate was maintained at 1.0 ml/min; column temperature was fixed at 35 °C and UV detection was carried out at 210 nm. The forced degradation studies were performed and method was validated with as per ICH guidelines.Results: The retention time of dimethyl fum

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