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Journal articles on the topic 'Chromatographic impurity'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

Nakov, Natalija, Rumenka Petkovska, Liljana Ugrinova, Suzana Trajkovic-Jolevska, and Aneta Dimitrovska. "Determination of Rocuronium bromide by hydrophilic interaction liquid chromatography (HILIC)." Macedonian Pharmaceutical Bulletin 57 (2001): 17–24. http://dx.doi.org/10.33320/maced.pharm.bull.2011.57.002.

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A new method involving hydrophilic interaction liquid chromatography (HILIC) has been developed for determination of rocuronium bromide in presents of its main impurities (impurity A and impurity C), which are also its main degradation products, in solution for injection. The influence of the critical chromatographic parameters such as content of acetonitrile in the mobile phase, ionic strength and pH value of the buffer used in the mobile phase were investigated using the Design of experiments approach (DoE). The mechanism of retention of rocuronium bromide on bare silica column was also inve

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Mule, Kishorkumar L., and Dnyandeo B. Pathare. "DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ISOSULFAN BLUE BY LIQUID CHROMATOGRAPHY." International Journal of Applied Pharmaceutics 9, no. 2 (2017): 42. http://dx.doi.org/10.22159/ijap.2017v9i2.16904.

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Objective: To develop and validate new, simple and rapid analytical method for determination of related impurities in isosulfan blue drug substances by the liquid chromatographic method as per ICH guidelines.Methods: The chromatographic separation obtained between drug substance i.e. isosulfan blue and its related impurities (Impurity-A, Impurity-B and Impurity-C) on C18 (100 x 2.00 mm) 1.9µ UPLC column using a mobile phase system containing 0.1 % perchloric acid in water (Mobile phase A) and 0.1 % perchloric acid in mixture of 30 volumes of water and 70 volumes of acetonitrile (Mobile Phase B

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3

Bor Fuh, C., and M. L. Wu. "Impurity analysis of methamidophos with chromatographic methods." Analytica Chimica Acta 395, no. 3 (1999): 257–63. http://dx.doi.org/10.1016/s0003-2670(99)00330-x.

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4

Lawande, Appasaheb Bajirao. "SEPARATION AND DETERMINATION OF THE R-ISOMER OF KETOPROFEN IN A BULK DRUG SUBSTANCE BY NORMAL PHASE LIQUID CHROMATOGRAPHY." Asian Journal of Pharmaceutical and Clinical Research 10, no. 1 (2016): 302. http://dx.doi.org/10.22159/ajpcr.2017.v10i1.15318.

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ABSTRACTObjective: The objective is defined to develop and validate simple, rapid, precise, and accurate for separation and determination of R-isomer impurityof ketoprofen bulk drug material by the normal phase high-performance liquid chromatographic method as per the International Conference ofHarmonization Guideline (ICH) guidelines.Methods: The R-isomer and S-isomer were baseline resolved on a Chiralcel OJ-H, 150 mm × 4.6 mm, and 5 µm stationary phase column. Mobile phasesystem containing n-hexane:isopropyl alcohol:glacial acetic acid (50:50:0.1 v/v.). The detector wavelength has been selec

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5

S., Mohan, Srinivasarao N., and Lakshmi K. "Development and Validation of a Stability indicating Related Substances of Baricitinib by RP-HPLC and its Degradation." International Journal of Management and Humanities (IJMH) 4, no. 2 (2019): 4–9. https://doi.org/10.35940/ijmh.A0369.104219.

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Reverse phase high performance liquid chromatography method, for estimation of related substances or chromatographic impurities of Barcitinib was developed and validated. Baricitinib was developed by separating its degradation products on a X-Terra RP18 (150x4.6mm, 5.0 µm) column using 0.1% Tri ethyl amine in water adjusted pH-2.5 with OPA and Acetonitrile in simple gradient at a flow rate 1.0 ml/min. The column effluents were monitored by a photodiode array detector set at 224nm. The method was validated in terms of specificity, linearity, accuracy, precision, detection limit, quantific

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Najana, Sanni Babu, and Bala Murali Krishna Khandapu. "Quantification of Impurity-E in Voriconazole Powder for Solution for Infusion (200 mg/vial) by using High Performance Liquid Chromatography." Caribbean Journal of Science and Technology 10, no. 02 (2022): 01–09. http://dx.doi.org/10.55434/cbi.2022.20101.

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A novel stability indicating liquid chromatographic method was developed and validated for the quantification of impurity-E((±)-βCamphorsulfonic acid, (±)-Camphor-10-sulfonic acid)in Voriconazole powder for solution for infusion formulation. The separation was achieved on Novapak (150 x 3.9 mm, 4 μm) column using a movable segment consisting of pH 5.0 acetate buffer and acetonitrile gradient elution mode, at a flow rate of 1.0 ml/min. Column oven maintained at 35°C, inoculation quantity 50 µl, sample cooler temperature 5 °C and detection wavelength 286 nm. Chromatographic resolution between im

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Raja, K. Durga, V. Saradhi Venkata Ramana, K. Raghu Babu, et al. "Development and Validation of UPLC-ESI-MS/MS Technique for the Determination of 2-Isopropyl-4-(chloromethyl)thiazole in Ritonavir." Asian Journal of Chemistry 32, no. 7 (2020): 1733–40. http://dx.doi.org/10.14233/ajchem.2020.22677.

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The objective of this work was to develop and validate a rapid, highly sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-ESI-MS/MS) method for the quantification of 2-isopropyl-4-(chloromethyl)thiazole in ritonavir. Chromatographic conditions of this impurity were achieved on an AQUITY UPLC column HSS (high strength silica) T3 column (100 mm long, 2.1 mm internal diameter, 1.8 μm diameter) using a gradient elution with 0.1% formic acid in water and methanol at a flow rate of 0.3 mL/min. LCMS/MS was operated under the multiple reaction mode (MRM) using electrospra

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8

Ronowicz, Joanna, Bogumiła Kupcewicz, Joanna Mydłowska, and Elżbieta Budzisz. "Impurity profile analysis of drug products containing acetylsalicylic acid: a chemometric approach." Open Chemistry 11, no. 7 (2013): 1091–100. http://dx.doi.org/10.2478/s11532-013-0243-2.

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AbstractIn this work attention is focused on impurity profile analysis in combination with infrared spectroscopy and chemometric methods. This approach is considered as an alternative to generally complex and time-consuming classic analytical techniques such as liquid chromatography. Various strategies for constructing descriptive models able to identify relations among drug impurity profiles hidden in multivariate chromatographic data sets are also presented and discussed. The hierarchical (cluster analysis) and non-hierarchical segmentation algorithms (k-means method) and principal component

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9

Boyd, Willard G. "Impurity Problems in Chromatographic Method Studies for Fenthion Formulations." Journal of AOAC INTERNATIONAL 68, no. 5 (1985): 925–29. http://dx.doi.org/10.1093/jaoac/68.5.925.

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Abstract Several gas chromatographic (GC) methods for analyzing fenthion were studied, and flame ionization detection, a glass column packed with SE-52 on Chromosorb GHP, and on-column injection were selected as parameters. No suitable internal standard was found because of coeluting, bias-producing impurities in fenthion. Several liquid chromatographic (LC) methods were also studied, and UV detection, a Zorbax ODS column, and a methanol-water-H3P04 mobile phase were finally selected as parameters. Dipentyl phthalate was selected as internal standard. After testing, this LC method was submitte

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10

Nawale, Rajesh, Shankar Pol, Prashant Puranik, Anwar Daud, and Vishal Rajkondawar. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE RELATED SUBSTANCE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE‑PHASE – HIGH‑PERFORMANCE LIQUID CHROMATOGRAPHY." Asian Journal of Pharmaceutical and Clinical Research 11, no. 10 (2018): 357. http://dx.doi.org/10.22159/ajpcr.2018.v11i10.27043.

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Objective: The objective of the study was to develop and validate new, simple, and selective reverse-phase–high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of Dabigatran Etexilate (DE) and its impurities in pharmaceutical dosage form as per the International Conference on Harmonization guidelines.Method: Chromatographic analysis was performed on Princeton SPHER-l00 C18 (250 × 4.6 mm, 5 μm) HPLC column, maintained at 50°C column temperatures, 6°C sample tray temperature, and detection monitored at 225 nm. The mobile phase consisted of acetonitrile:phosp

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11

Kirchhoefer, Ross D. "Gas Chromatographic/Mass Spectrometric Identification of a Pyridinedicarboxylic Acid Impurity in Niacin as the Trimethylsilyl Ester." Journal of AOAC INTERNATIONAL 77, no. 1 (1994): 117–20. http://dx.doi.org/10.1093/jaoac/77.1.117.

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Abstract A pyridinedicarboxylic acid impurity in bulk niacin was identified by derivatization and comparison with reference materials by using gas chromatogra-phy/mass spectrometry. The niacin bulk material was dissolved in pyridine and derivatized with N,O-bis(trimethylsilyl)trifluoroacetamide (BSTFA) reagent. The resulting trimethylsilyl (TMS) esters of niacin and its associated impurities were chromatographed on a cross-linked methyl silicone capillary column with temperature programming. Derivatization and injection of the 6 pyridinedicarboxylic acid geometric isomers showed that 3 of the

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12

Tarapon, K. V., and O. V. Tryhubchak. "Development and validation method for the determination of related substances in nimesulide granules for oral suspension." Current issues in pharmacy and medicine: science and practice 15, no. 3 (2022): 259–65. http://dx.doi.org/10.14739/2409-2932.2022.3.259472.

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One of the key stages of pharmaceutical development is the development of analytical methods for quality control of medicines. The critical quality indicator is the content of related impurities, which may increase during shelf life of the product due to the degradation of the active substance, which in turn affects the quality of the product. The aim of the work is to develop and validate the method for the determination of related impurities in nimesulide granules for oral suspension by HPLC method; to set the specification of finished product for related impurities. Materials and methods. S

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13

Vijayaraj, Surendran, Narahari N. Palei, and Thummala Katyayani. "Quality by Design (Qbd) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug." Current Pharmaceutical Analysis 15, no. 7 (2019): 716–23. http://dx.doi.org/10.2174/1573412914666180523092012.

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Background:Gliclazide Impurity A (GI-A) is one of the gliclazide impurities, as described in the European Pharmacopoeia.Objective:The objective of this study was to develop and validate simple, robust and accurate Reverse- Phase High-Performance Liquid Chromatography (RP-HPLC) method for estimation of gliclazide along with GI-A in bulk by optimising chromatographic parameters using Box Behnken design in response surface methodology.Methods & Results:Box Behnken design was employed for optimizing flow rate, injection volume and strength of the buffer in order to minimize retention time of b

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14

Phuge, Ashish, Rekha Bhalerao, and Vijaya Barge. "A Review On Chromatographic Method Development And Impurity Profiling." PDEAS International Journal of Research in Ayurved and Allied Sciences 1, no. 1 (2019): 28–32. https://doi.org/10.63778/pdeasijraas-arjcpl/2019_21530.

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Stability indicating assay method (SIAM) is a validated quantitative analytical procedure that can detect changes with time in the properties of the drug substance and drug product under defined storage conditions. It accurately measures the API without interference from other substances and is sensitive enough to detect and quantify even small amounts of degradation products/impurities. To develop a SIAM, stress testing in the form of forced degradation should be carried out as per International Conference On Harmonization (ICH) Guidelines at an early stage so that impurities and degradation

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15

Mazzarino, Randall C., Tissa J. Thomas, and Ryan E. Sours. "Chromatographic determination of impurity binding affinities on biomineral crystals." CrystEngComm 13, no. 4 (2011): 1096–102. http://dx.doi.org/10.1039/c0ce00454e.

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16

Dumarey, M., R. Sneyers, W. Janssens, I. Somers, and Y. Vander Heyden. "Drug impurity profiling: Method optimization on dissimilar chromatographic systems." Analytica Chimica Acta 656, no. 1-2 (2009): 85–92. http://dx.doi.org/10.1016/j.aca.2009.10.013.

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17

Riad, Safaa M., Mohamed K. Abd El-Rahman, Esraa M. Fawaz, and Mostafa A. Shehata. "A New Platform for Profiling Degradation-Related Impurities Via Exploiting the Opportunities Offered by Ion-Selective Electrodes: Determination of Both Diatrizoate Sodium and Its Cytotoxic Degradation Product." Journal of AOAC INTERNATIONAL 101, no. 3 (2018): 723–31. http://dx.doi.org/10.5740/jaoacint.16-0369.

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Abstract Although the ultimate goal of administering active pharmaceutical ingredients (APIs) is to save countless lives, the presence of impurities and/or degradation products in APIs or formulations may cause harmful physiological effects. Today, impurity profiling (i.e., the identity as well as the quantity of impurity in a pharmaceutical) is receiving critical attention from regulatory authorities. Despite the predominant use of spectroscopic and chromatographic methods over electrochemical methods for impurity profiling of APIs, this work investigates the opportunities offered by electroa

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18

Krakowska, B., D. Custers, E. Deconinck, and M. Daszykowski. "The Monte Carlo validation framework for the discriminant partial least squares model extended with variable selection methods applied to authenticity studies of Viagra® based on chromatographic impurity profiles." Analyst 141, no. 3 (2016): 1060–70. http://dx.doi.org/10.1039/c5an01656h.

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19

Song, Min, Sha Wu, Ping-bo Lu, Ya-nan Qiao, and Tai-jun Hang. "A selective and sensitive pre-column derivatization HPLC method for the trace analysis of genotoxic impurity hydroxylamine in active pharmaceutical ingredients." Analytical Methods 8, no. 47 (2016): 8352–61. http://dx.doi.org/10.1039/c6ay02675c.

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A simple and robust high-performance liquid chromatographic (HPLC) method for the trace analysis of genotoxic impurity hydroxylamine in Vorinostat and Zileuton, two active pharmaceutical ingredients, is described.

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Prajapati, Pintu B., Navneet Wankhed, and Priti J. Mehta. "A Review on Multi Approaches for Impurity Isolation and its Characterization." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 793–802. http://dx.doi.org/10.22270/jddt.v9i4-a.3627.

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International Conference on Harmonization (ICH) has formulated different guideline regarding the control of impurities. In this review, the impurity sources, classification, isolation, detection and characterization methods are described. The some impurities are unavoidable and will be present in trace amounts hence ICH guidelines frame the different policies and establish the specification limits, isolation and characterization is necessary for evaluation and control of impurities. The other regulatory bodies and drug development authorities look up to these guidelines for launching a quality

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Tayupov, M. M., M. F. Abdullin, A. V. Markova, and A. M. Safronov. "COMPREHENSIVE USE OF GAS CHROMATOGRAPHY-MASS SPECTROMETRY AND DISSOCIATIVE ELECTRON ATTACHMENT SPECTROSCOPY METHODS TO DETERMINE THE ISOMERIC COMPOSITION OF SAMPLES." Izvestia Ufimskogo Nauchnogo Tsentra RAN, no. 3 (September 4, 2024): 9–14. http://dx.doi.org/10.31040/2222-8349-2024-0-3-9-14.

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Due to the fact that in environmental and biomedical sciences there is an ever-growing need to detect traces of toxins (xenobiotics) and analyze specific target substances in complex test samples, various types of equipment related to analytical chemistry are growing and multiplying. The paper shows the possibility of using gas chromatography-mass spectrometry and spectroscopy of dissociative electron attachment in conjunction with quantum mechanical calculations using the density functional theory method to refine the results of the analysis of the isomeric composition of the studied samples.

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Mount, Dwight L., James W. Miles, and Frederick C. Churchill. "Liquid Chromatographic and Spectroscopic Characterization of Pentamidine Isethionate and Impurities in Bulk Drug and Injectables." Journal of AOAC INTERNATIONAL 69, no. 4 (1986): 624–29. http://dx.doi.org/10.1093/jaoac/69.4.624.

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Abstract A liquid chromatographic (LC) method is described for evaluating purity of pentamidine isethionate (PI), a life-saving drug used in the treatment of Pneumocystis carinii pneumonia, which is a leading cause of death in persons with acquired immunodeficiency syndrome (AIDS). Six potential impurity compounds were synthesized to test the selectivity of the chromatographic system and to permit quantitation of impurities in various lots of PI products. The drug and impurities were separated with gradient elution on a cyano-bonded LC column. The analytic system provided information on the id

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Sagar, Pagade* Sahil Agrawal Prathmesh Shejal Pranjal Chougule Nilesh Chougule. "Detection Of Impurities: A Review On Advance In Impurities Detection And Characterization In Pharmaceuticals By Analytical Techniques." International Journal in Pharmaceutical Sciences 1, no. 12 (2023): 860–79. https://doi.org/10.5281/zenodo.10433875.

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The detection and characterization of impurities in pharmaceuticals are pivotal aspects of ensuring the safety, efficacy, and quality of drug products. This review provides a comprehensive overview of the analytical techniques employed in the identification and quantification of impurities at various stages of pharmaceutical development, manufacturing, and quality control. Chromatographic methods, including High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC), are foundational for their ability to separate complex mixtures. Mass spectrometry (MS) and Nuclear Magnetic Reson

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Narapereddy, Krishan Prasad, and Devi Sravanthi Alladi. "Development and validation of determination of genotoxic impurity Bromoethane in Vigabatrin drug substance using head space gas chromatographic method [HS-GC]." Pharmacia 70, no. 1 (2023): 203–7. http://dx.doi.org/10.3897/pharmacia.70.e97339.

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A specific HS-GC method has been developed, optimized, and validated for the determination of genotoxic impurity Bromoethane in Vigabatrin (VGB) drug substance. Chromatographic separation of genotoxic Bromoethane impurity was achieved on DB-1 column (30 m × 0.53 mm, 5.0 μm), consists of 100% dimethyl polysiloxane as stationary phase and passing nitrogen carrier gas. The performance of the method was assessed by evaluating the specificity, linearity, sensitivity, precision, and accuracy experiments. The established limit of detection and limit of quantification values for the genotoxic impurity

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Narapereddy, Krishan Prasad, and Devi Sravanthi Alladi. "Development and validation of determination of genotoxic impurity Bromoethane in Vigabatrin drug substance using head space gas chromatographic method [HS-GC]." Pharmacia 70, no. (1) (2023): 203–7. https://doi.org/10.3897/pharmacia.70.e97339.

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A specific HS-GC method has been developed, optimized, and validated for the determination of genotoxic impurity Bromoethane in Vigabatrin (VGB) drug substance. Chromatographic separation of genotoxic Bromoethane impurity was achieved on DB-1 column (30 m × 0.53 mm, 5.0 μm), consists of 100% dimethyl polysiloxane as stationary phase and passing nitrogen carrier gas. The performance of the method was assessed by evaluating the specificity, linearity, sensitivity, precision, and accuracy experiments. The established limit of detection and limit of quantification values for the genotoxic impurity

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Chakravarthy, V. Ashok, B. B. V. Sailaja, and Avvaru Praveen Kumar. "Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms." Journal of Analytical Methods in Chemistry 2015 (2015): 1–11. http://dx.doi.org/10.1155/2015/735145.

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The present work was the development of a simple, efficient, and reproducible stability-indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method for simultaneous determination enrofloxacin (EFX) and its degradation products including ethylenediamine impurity, desfluoro impurity, ciprofloxacin impurity, chloro impurity, fluoroquinolonic acid impurity, and decarboxylated impurity in tablet dosage forms. The separation of EFX and its degradation products in tablets was carried out on Kromasil C-18(250×4.6 mm, 5 μm) column using 0.1% (v/v) TEA in 10 mM KH2PO4(pH 2.5) buffe

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Tomić, Jovana, Branka Ivković, Slavica Oljačić, et al. "Chemometrically assisted RP-HPLC method development for efficient separation of ivabradine and its eleven impurities." Acta Chromatographica 32, no. 1 (2020): 53–63. http://dx.doi.org/10.1556/1326.2019.00659.

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The aim of this study was to develop a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method for efficient separation of ivabradine and its 11 impurities. Similar polarity of impurities in the sample mixture made method optimization challenging and accomplishable only when different chemometric tools, such as principal component analysis (PCA), Box–Behnken design (BBD), and desirability function as a multicriteria approach, were employed. The presence of 3 positional isomers (impurities III, V, and VI), keto–enol tautomerism of impurity VII, and diastereoisomers of impur

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Papadasu, Narayanareddy, and Ramakrishna Reddy K. "A NOVEL VALIDATED STABILITY INDICATIVE UPLC METHOD FOR RELUGOLIX FOR THE DETERMINATION OF PROCESS-RELATED AND DEGRADATION IMPURITIES." Rasayan J. Chem 17, no. 02 (2024): 325–36. http://dx.doi.org/10.31788/rjc.2024.1728767.

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A Novel Stability-indicating ultra-performance liquid chromatographic (UPLC) method has been developed for the quantitative determination of Relugolix, API along with its four process-related impurities (Impurity-1, Impurity-2, Impurity-3, Impurity-4) and its degradation impurities. The method was applicable for the quantification of related substances and assay in Relugolix. Efficient chromatographic separation was achieved by using BEH RP-18 column, 100 x 2.1 mm, 1.7 µm, and gradient mobile phase with a run time of 10 minutes. The mobile phase contains a gradient of solvent A (1 % orthophosp

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R, Bachhav. "Recent Approaches of Impurity Profiling in Pharmaceutical Analysis: A Concise Review." Medicinal & Analytical Chemistry International Journal 8, no. 1 (2024): 1–14. http://dx.doi.org/10.23880/macij-16000191.

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Purity profiling is the process of gathering and analyzing information to determine the biological safety of a specific impurity, hence highlighting its importance and range in pharmaceutical research. In the field of pharmaceuticals, impurity has no precise meaning. Identification, structural elucidation, and quantitative determination of impurities and degradation products in bulk medicinal materials and pharmaceutical formulations are all included in impurity profiling. Since unrecognized, possibly poisonous impurities are dangerous to health and should be found and determined by selective

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LAZĂR, LILIANA, (BĂLUȘESCU) GEORGIANA MARDARE, and DUMITRU COMAN. "Qualitative And Quantitative Analysis of Impurities in Chlorocholine Chloride: A Review." Buletinul Institutului Politehnic din Iași, Secția Chimie și Inginerie Chimică 70, no. 2 (2024): 77–91. https://doi.org/10.5281/zenodo.13308330.

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This study provides an overview of impurities in an active substance / active ingredient and selective analytical methods of impurities for their identification in chlorocholine chloride with applications and literature references. Moreover, its reviews the importance to understanding what determinates an impurity and identification of potential sources of this impurity is discussed. The analytes include 1,2-dichloroethane and trimethylamine which are relevant impurities acceptable by Food and Agriculture Organization of the United Nations and World Health Organization. After a concise resume

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Duhaime, Randy M., Lorna K. Rollins, Dennis J. K. Gorecki, and Edward G. Lovering. "Liquid Chromatographic Determination of Cromolyn Sodium and Related Compounds in Raw Materials." Journal of AOAC INTERNATIONAL 77, no. 6 (1994): 1439–42. http://dx.doi.org/10.1093/jaoac/77.6.1439.

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Abstract Liquid chromatographic methods for the assay of cromolyn sodium and 3 related compounds were developed. The methods, which differ only in the composition of the mobile phase, use an octadecylsilane bonded-phase column and an acetonitrile–water–cetyltrimethylammonium bromide mobile phase. Minimum quantitatable amounts of the related compounds were less than 0.05%; assay method precision was better than 1 %. Impurity levels in raw material samples from 4 manufacturers were less than 0.1 %.

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Studzińska, Sylwia, Feiyang Li, Michał Szumski, Bogusław Buszewski, and Michael Lämmerhofer. "Cholesterol Stationary Phase in the Separation and Identification of siRNA Impurities by Two-Dimensional Liquid Chromatography-Mass Spectrometry." International Journal of Molecular Sciences 23, no. 23 (2022): 14960. http://dx.doi.org/10.3390/ijms232314960.

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The aim of this research was to develop a simple and efficient ion-pair reagent-free chromatographic method for the separation and qualitative determination of oligonucleotide impurities, exemplified by synthesis of raw products of the two single strands of patisiran siRNA. The stationary phases with mixed hydrophobic/hydrophilic properties (cholesterol and alkylamide) were firstly used for this purpose with reversed-phased high-performance liquid chromatography. Several different chromatographic parameters were tested for their impact on impurities separation: type, concentration, pH of salt,

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Kirakosyan, Virab G., Samvel M. Vardapetyan, Lusine H. Varderesyan, and Avetis H. Tsaturyan. "DEVELOPMENT OF A RAPID AND EFFICIENT METHOD FOR QUANTITATIVE DETERMINATION OF N-NITROSODIMETHYLAMINE IMPURITY BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN METFORMIN HYDROCHLORIDE, LOSARTAN POTASSIUM, VALSARTAN AND RANITIDINE MEDICINAL RAW MATERIALS AND ITS PRODUCTS." Proceedings of the YSU B: Chemical and Biological Sciences 55, no. 3 (256) (2021): 296–99. http://dx.doi.org/10.46991/pysu:b/2021.55.3.296.

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In this study, chromatographic conditions were developed for the separation and quantification of N-nitrosodimethylamine (NDMA) by HPLC. Our method would be useful for the rapid screening and quantification of NDMA impurity in Metformin hydrochloride, Losartan potassium, Valsartan and Ranitidine drugs substance and its products. The chromatographic separation was achieved on a Phenomenex C18 column (250 mm, 5 µm, 4.6 mm) by multistep gradient elution, using a water-acetonitrile mobile phase containing 0.1% formic acid, which provided better c hromatographic separation. Column temperature was m

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Kurdaikar, S. S., A. Fernandes, S. V. Gandhi, P. Pattewar, and A. A. Mahajan. "Spectrophotometric Determination of Carbimazole and Its Major Impurity, Degradation Product and Metabolite: Methimazole -=SUP=-*-=/SUP=-." Оптика и спектроскопия 129, no. 7 (2021): 972. http://dx.doi.org/10.21883/os.2021.07.51090.1046-21.

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The present research work was carried out in order to develop simple, accurate and precise UV sprctrophotometric methods having comparable sensitivity as that of sophisticated chromatographic techniques. Two methods were developed namely first derivative spectrophotometry and ratio spectra derivative spectrophotometry for accurate determination of specified impurity methimazole (imp A) in presence of drug carbimazole. First derivative spectrophotometric method involves recording of zero order spectra of both the drugs carbimazole and methimazole and its mixture in the range of 200-400 nm and s

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Dong, Michael W., Peter V. Passalacqua, and Dilip R. Choudhury. "Liquid Chromatographic Considerations for High Sensitivity Impurity and Stability Testing of Pharmaceuticals." Journal of Liquid Chromatography 13, no. 11 (1990): 2135–60. http://dx.doi.org/10.1080/01483919008049020.

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Casale, John F., and Richard W. Waggoner. "A Chromatographic Impurity Signature Profile Analysis for Cocaine Using Capillary Gas Chromatography." Journal of Forensic Sciences 36, no. 5 (1991): 13154J. http://dx.doi.org/10.1520/jfs13154j.

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B'Hymer, C. "Evaluation of a Capillary Gas Chromatographic Impurity Test Procedure for 4-Hexylaniline." Journal of Chromatographic Science 43, no. 5 (2005): 267–70. http://dx.doi.org/10.1093/chromsci/43.5.267.

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Shinde, Vikas R., Anurag Trivedi, P. R. Upadhayay, N. L. Gupta, D. G. Kanase, and Rajeev C. Chikate. "Isolation and characterization of benazepril unknown impurity by chromatographic and spectroscopic methods." Journal of Pharmaceutical and Biomedical Analysis 42, no. 3 (2006): 395–99. http://dx.doi.org/10.1016/j.jpba.2006.04.005.

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Sanger, D. G., I. J. Humphreys, A. C. Patel, M. Japp, and R. G. L. Osborne. "The significance of gas chromatographic impurity patterns obtained from illicitly produced amphetamine." Forensic Science International 28, no. 1 (1985): 7–17. http://dx.doi.org/10.1016/0379-0738(85)90160-4.

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Hossain, PhD, Mohammad F., Mamoon Rashid, PhD, Randy Mullins, PharmD, et al. "Chemical stability of naloxone products beyond their labeled expiration dates." Journal of Opioid Management 18, no. 1 (2022): 39–46. http://dx.doi.org/10.5055/jom.2022.0693.

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Objective: The purpose of this study was to evaluate the chemical stability of previously dispensed, expired naloxone products.Setting: When properly stored, certain products maintain stable, defined as within compendia acceptability, beyond their manufacturer's expiration date. Stockpiling life-saving medications such as the opioid overdose reversing agent naloxone nasal spray (NNS) or injection (NIJ) is of utmost importance to ensure public health emergency preparedness and response.Design/interventions/methods: After each naloxone product was stored at room temperature for several months (6

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Piponski, Marjan, Tanja Bakovska Stoimenova, Magdalena Piponska, and Gordana Trendovska Serafimovska. "oncepts in development of fast, simple, stability indicating HPLC method for analysis of atorvastatin related compounds in tablets." Journal of Analytical & Pharmaceutical Research 7, no. 4 (2018): 450–57. http://dx.doi.org/10.15406/japlr.2018.07.00265.

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New, fast, simple and mild conditioned High Performance Liquid Chromatography (HPLC) method for determination of atorvastatin and its 7 main specified impurities, as well as unspecified impurities that might possibly appear, was developed. Chromatographic runs last between 25 and 40 minutes, with simple stepwise gradient elution. The main accent in our method development strategy was focused on mobile phase, composed of simple binary system composed of phosphate buffer and acetonitrile, at pH 4.1, without use of tetrahydrofuran, ion-pair reagents, trifluoroacetic acid and other modifiers with

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Gao, Li Ping, Wen Juan Li, and Xin Ping Wang. "A Validated Chiral HPLC Method for the Enantiomeric Separation of Melphalan HCl." Advanced Materials Research 781-784 (September 2013): 993–98. http://dx.doi.org/10.4028/www.scientific.net/amr.781-784.993.

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A new and accurate chiral HPLC method was developed for the determination of Melphalan HCl, L-Phenylalanine, 4-bis (2-chloroethyl) amino hydrochloride an anti-cancer chemotherapy drug and its potential impurity namely D-Phenylalanine, 4-bis (2-chloroethyl) amino hydrochloride ( D-enantiomer) in bulk substance. HPLC separation was carried out by reverse phase chromatography on Crownpak CR (+) (5μm, 4.0x150mm) with a mobile phase composed of perchloric acid (pH 4.0): methanol in the ratio of 90:10. Melphalan and its potential impurities were baseline resolved in the optimized method. The pH of p

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Deshoju, Srinu* B. Jainendra Kumar. "A Review on Gas Chromatography: Techniques, Methodologies, and Applications-Implications to Pharmaceutical Research." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 837–48. https://doi.org/10.5281/zenodo.14857270.

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Gas chromatography (GC) is a powerful analytical technique used for the separation, identification, and quantification of volatile and semi-volatile compounds. This review explores the fundamental principles of GC, focusing on its working mechanism, stationary phases, column selection, operational conditions, sample introduction techniques, detection devices, and detection processes. Additionally, it covers qualitative and quantitative methods, applications in drug substance development, sample preparation techniques, derivatization methods, and chiral gas chromatographic applications. The art

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Sozin, A. Yu, O. Yu Chernova, T. G. Sorochkina, O. Yu Troshin, and A. P. Kotkov. "Study of the impurity composition of silicon tetrachloride by gas chromatography-mass-spectrometry." Industrial laboratory. Diagnostics of materials 90, no. 3 (2024): 5–11. http://dx.doi.org/10.26896/1028-6861-2024-90-3-5-11.

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Silicon tetrachloride is a sought-after substance in the semiconductor and optoelectronics industries. High demands placed on its purity entail the need for detail information about the impurities present. The impurity composition of silicon tetrachloride obtained by different technologies (chlorination of diatomite and charcoal, disproportionation of trichlorosilane and chlorination of isotopically enriched silicon) was studied using the method of chromatography-mass spectrometry. Study of the possibility of using a DB-5MS 30 m × 0.32 mm × 0.25 μm capillary column with methylsiloxane as a sta

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Lawande, Appasaheb Bajirao. "RAPID SEPARATION AND DETERMINATION OF RIZATRIPTAN N-OXIDE IMPURITY IN RIZATRIPTAN BENZOATE IN A BULK DRUG SUBSTANCE BY REVERSE PHASE LIQUID CHROMATOGRAPHY." Asian Journal of Pharmaceutical and Clinical Research 10, no. 2 (2017): 372. http://dx.doi.org/10.22159/ajpcr.2017.v10i2.15751.

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Objective: The objective is described to develop and validate a simple, reliable, precise, and specific analytical method for rapid separation and determination of N-oxide impurity in rizatriptan Benzoate active pharmaceutical ingredient bulk drug substances by reverse phase liquid chromatography as per the International Conference on Harmonization (ICH) guidelines.Methods: The methodology utilized as reverse phase liquid chromatography with gradient composition. The mobile phase proportion was compromised mobile A containing 0.25 mm potassium dihydrogen phosphate buffer pH 2.0 and methanol (9

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Zhelubayeva, K., and T. Arystanova. "IDENTIFICATION OF ACTIVE INGREDIENTS AND RELATED IMPURITIES IN A COMBINED DRUG PREPARATION USING THIN LAYER CHROMATOGRAPHY METHOD." Farmaciâ Kazahstana, no. 6 (January 23, 2025): 230–37. https://doi.org/10.53511/pharmkaz.2025.39.77.030.

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The pharmaceutical analysis of combined drugs is associated with certain difficulties associated with the simultaneous detection of active ingredients and their related impurities in one drug. This paper presents the first developed method for the identification of active ingredients and possible concomitant impurities in the combined antiviral drug “Glitsavir” using thin-layer chromatography. Optimal conditions for chromatographic analysis were selected and the validation characteristics of the method — specificity, robustness and precision — were studied. Validation characteristics were stud

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Kumar, G. T. Jyothesh, B. S. A. Andrews, V. D. N. Kumar Abbaraju, Sreeram V., P. Sunil Reddy, and Avinash Rai Kola. "QUANTITATIVE ANALYSIS OF MIRABEGRON ER TABLETS: A COMPREHENSIVE RP-HPLC METHOD AND VALIDATION FOR THE IMPURITY DETERMINATION." RASAYAN Journal of Chemistry 17, no. 03 (2024): 1315–23. http://dx.doi.org/10.31788/rjc.2024.1738809.

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This research aimed to design as well as evaluate reverse-phase high-performance liquid chromatography (RPHPLC) process to precise quantification for potential impurities in Mirabegron (MIRA) ER Tablets. The developed method utilized an Inertsil C8 - 3, 150 x 4.6 mm, 3µm column with a gradient elution program utilizing Buffer and Acetonitrile as mobile phases. The chromatographic separation achieved on a C8 stationary phase demonstrated robustness and reproducibility, with detection at a wavelength of 240 nm and a constant column temperature of 40°C. The research study was focused on MIRA and

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Gigopulu, Olga, Hrisanta Godzo, Biljana Atanasovska, et al. "Green RP-HPLC method for impurity profile of amlodipine in tablets." Arhiv za farmaciju 74, no. 2 (2024): 216–34. http://dx.doi.org/10.5937/arhfarm74-49799.

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Increased awareness of nature preservation has encouraged the introduction of the green analytical chemistry (GAC) practice concepts concerning several important aspects, including sustainable development, environmental impact, and minimum waste. The aim of this research was to contribute to the implementation of this approach for the pharmaceutical industry while retaining the crucial aspects and strict requirements of quality control of medicines. Therefore, an ethanolbased, green and robust high-performance liquid chromatography (HPLC) method for the determination of related substances of a

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Patel, Binal N., and Hitesh J. Vekaria. "A Stability Indicating Reverse Phase High Performance Liquid Chromatography Method for Related Substances of Sofosbuvir in Tablet Dosage Form." International Journal of Pharmaceutical Sciences and Drug Research 15, no. 05 (2023): 547–55. http://dx.doi.org/10.25004/ijpsdr.2023.150501.

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Sofosbuvir is an antiviral drug that is used to treat hepatitis C. A present investigation deals with simple, sensitive, rapid, precise and accurate reverse phase high-performance chromatography (RP-HPLC) method developed and validated for related substances of sofosbuvir in tablet dosage form. The chromatographic separation was achieved on a Kromasil 100 C18 (250 × 4.6 mm, 5 μ) column. A sofosbuvir and its impurities were extracted by composed mixture of Mobile Phase A: buffer solution: acetonitrile (97.5:2.5% v/v) and Mobile Phase B: acetonitrile, isopropyl alcohol, methanol and purified wat

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Sanket, S. Gite Nikit S. Thakare Aditi A. Kokande Aniket B. Bairagi Shubham R. Jadhav Himmat D. Sawant. "Cutting edge Techniques for Impurity Profiling in Pharmaceutical Analysis: A brief Overview." International Journal in Pharmaceutical Sciences 1, no. 11 (2023): 571–87. https://doi.org/10.5281/zenodo.10213447.

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Purity profiling involves the meticulous gathering and analysis of information to ascertain the biological safety of specific impurities, underscoring its crucial role and extensive scope within pharmaceutical research. In the realm of pharmaceuticals, the term "impurity" lacks a precise definition. Impurity profiling encompasses the identification, structural clarification, and quantitative assessment of impurities and degradation products present in bulk medicinal materials and pharmaceutical formulations. Given that undisclosed and potentially harmful impurities pose a threat to health, the

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