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Journal articles on the topic 'Acetonitrile And Validation'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Jeong, Min Kyu, Chan Uk Park, Min Hee Park, et al. "Validation of HPLC Methods for Ascorbic Acid and Its Derivatives in Foods." Food Engineering Progress 15, no. 1 (2011): 75–79. http://dx.doi.org/10.13050/foodengprog.2011.15.1.75.

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Analytical methods for food antioxidants including ascorbic acid, erythorbic acid, ascorbyl palmitate (AP), and ascorbyl stearate (AS), were validated using high performance liquid chromatography. Validation parameters such as linearity, limit of detection (LOD), limit of quantification (LOQ), and recovery were tested using lard and cider as food model systems. Linearity of ascorbic acid and erythorbic acid were both higher than (R2> 0.99), LOD of these compounds were 0.46 and 0.48 μg/mL, respectively and LOQ were 1.39 and 1.45 μg/mL, respectively. The recovery rates of these compounds were

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Suryawanshi, Shivraj Vithal, Omprakash G. Bhusnure, S. M. Vijayendra Swamy, Sachin B. Gholve, Padmaja S. Girm, and Mahesh J. Birajdar. "Development and Validation of a RP-UPLC Method for Determination of Linezolid in Pharmaceutical Formulation." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 654–58. http://dx.doi.org/10.22270/jddt.v9i3-s.3072.

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A simple, sensitive and accurate RP-UPLC method has been developed for the determination of Linezolid in Tablet formulation. The mix of the Linezolid was found to be 251nm in Acetonitrile: Buffer [40:60(v/v)]. The method shows high sensitivity with linearity 5 to 30μg/ml (regression r2 = 0.999). This method was tested and validated for various parameters according to ICH guidelines and USP. The Detection limit and quantitation limit were found to be 50mg ml–1 and 150 mg ml–1 in Acetonitrile: Buffer [40:60(v/v)] respectively. The results demonstrated that the procedure is accurate, precise and

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3

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

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

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Abd El-Mageed, Nasra M., Ideisan I. Abu-Abdoun, Khawla A. O. Al Shurafa, Dinesh K. Saseendran, Arwa Y. A. Binbasher, and Jalal H. Khataibeh. "Validation of Commercial Formulation of Difenoconazole Using HPLC Equipped with Dad." Global Research in Environment and Sustainability 2, no. 6 (2024): 18–30. http://dx.doi.org/10.63002/gres.26.507.

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Effective, selective, precise, and accurate liquid chromatographic analytical methods for the determination of difenoconazole fungicide in the formulation have been optimized and validated to meet the accreditation requirements, the performance characteristics of the analytical method were validated which is also one of the basic requirements of ISO Standard 17025:2017, for the rapid determination of difenoconazole by HPLC-DAD. The used method involves the extraction of the substances by sonication of the sample with acetonitrile, followed by dilution in acetonitrile, and direct injection on a

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Ogale, Shital Ashokrao* Madhav A. Shetkar. "Method Development And Validation Of Asciminib By RPHPLC." International Journal in Pharmaceutical Sciences 2, no. 6 (2024): 278–86. https://doi.org/10.5281/zenodo.11486334.

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Another methodology was set up for synchronous estimation of a Asciminib by RP-HPLC system. The chromatographic conditions were viably created for the unit of Asciminib by using Inertsil - ODS C18(250 x 4.6 mm, 5µ), stream is 1.0 ml/min, convenient stage extent was Methanol: Acetonitrile (60:40), recognizable proof wave length was 274nm.

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Mehendale, P. C., R. B. Athawale, and K. K. Singh. "DEVELOPMENT AND VALIDATION OF RAPID AND SIMPLE BIOANALYTICAL METHOD FOR DOCETAXEL WITH ONE STEP PROTEIN PRECIPITATION." INDIAN DRUGS 56, no. 07 (2019): 23–32. http://dx.doi.org/10.53879/id.56.07.11501.

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A rapid and simple bio-analytical method with one step protein precipitation and extraction using acetonitrile as extraction solvent was developed for docetaxel. The extraction efficiency was 87.81% with satisfactory separation of docetaxel and IS peaks by isocratic elution with C18 column (25 cm X 4.5 mm, 0.5μm), acetonitrile and water (53:47 % V/V) as a mobile phase at ambient temperature and flow rate of 1mL/min. Paclitaxel solution in acetonitrile (10 mcg/ mL) was used as internal standard. The calibration curve was linear over the concentration range 50 – 5000 ng/mL, regression coefficien

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7

Simranjeet, Singh Muskan Sood Anu Jindal* Rajmeet Singh Satvinder Kaur Jaswinder Singh Shaveta Bhardwaj. "Analytical Method Validation of Tablet Dosage Form of Lurasidone HCl." International Journal in Pharmaceutical Sciences 1, no. 11 (2023): 240–45. https://doi.org/10.5281/zenodo.10112998.

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This research is mainly focused on development of an Excellent Gradient method by reverse phase - high performance liquid chromatography (RP-HPLC) using UV Visible Detector. The main objective of method validation of Lurasidone HCl as a tablet dosage form is to validate the method as in-house method. As this tablet dosage form is not registered in any of Pharmacopeia, so the method is developed and validated for further studies. The sample is analyzed by RP-HPLC using octadecylsilane (C18) column (Inertsil LC-GC) as stationary phase with UV-Visible detector. The 'Gradient Method' is used as in

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8

Posyniak, Andrzej, Jan Zmudzki, Richard L. Ellis, et al. "Validation Study for the Determination of Tetracycline Residues in Animal Tissues." Journal of AOAC INTERNATIONAL 82, no. 4 (1999): 862–65. http://dx.doi.org/10.1093/jaoac/82.4.862.

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Abstract An interlaboratory study of the liquid chromatographic (LC) determination of tetracyclines—oxytetracycline (OTC), tetracycline (TTC), and chlortetracycline (CTC)—in animal tissues was conducted. Isolation was performed with oxalic buffer followed by dechelation and deproteination with oxalic acid–acetonitrile. The extract was cleaned with a styrene–divinylbenzene cartridge. LC analysis was performed with a PLRP-S column and 0.01 M oxalic acid–acetonitrile (75 + 25, v/v) as mobile phase. Participants analyzed 2 control and 10 fortified porcine muscle and kidney samples. Additionally, p

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9

Vázquez-Villegas, Paola T., Rocío Meza-Gordillo, María C. Luján-Hidalgo, et al. "Optimization and Validation of an Extraction Method for Endosulfan Lactone on a Solid Substrate." Processes 9, no. 2 (2021): 284. http://dx.doi.org/10.3390/pr9020284.

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Endosulfan lactone is a metabolite obtained from the biological oxidation of the insecticide endosulfan by action of the microorganisms present in the soil. This metabolite is more toxic and persistent than the parent compound. Therefore, it is extremely important to be able to determine the presence of this metabolite in the soil. However, accessible methods for extraction of endosulfan lactone in soil were not found in published literature. For this reason, the aim of this study was to evaluate two conventional methods of liquid–solid extraction for the determination of endosulfan lactone in

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Simranjeet, Singh Muskan Sood Anu Jindal* Rajmeet Singh Satvinder Kaur Jaswinder Singh Shaveta Bhardwaj. "Analytical Method Validation of Tablet Dosage Form of Lurasidone HCl." International Journal in Pharmaceutical Sciences 1, no. 11 (2023): 240–45. https://doi.org/10.5281/zenodo.10113218.

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This research is mainly focused on development of an Excellent Gradient method by reverse phase - high performance liquid chromatography (RP-HPLC) using UV Visible Detector. The main objective of method validation of Lurasidone HCl as a tablet dosage form is to validate the method as in-house method. As this tablet dosage form is not registered in any of Pharmacopeia, so the method is developed and validated for further studies. The sample is analyzed by RP-HPLC using octadecylsilane (C18) column (Inertsil LC-GC) as stationary phase with UV-Visible detector. The 'Gradient Method

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Dr., K. Bhavyasri, tasneem Sumaiya, and Mogili. Sumakanth Dr. "Development and Validation of a UV-Visible Spectrophotometer Method for Estimation of Etomidate Spiked in Human Plasma." Journal of Scientific and Engineering Research 8, no. 7 (2021): 166–71. https://doi.org/10.5281/zenodo.10609123.

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<strong>Abstract </strong>UV-visible spectrophotometer method for determination of etomidate in human plasma was developed and validated. Acetonitrile and water (75:25) as diluent. The absorption maximum for the drug was observed at 243nm in methanol. The calibration curve range from 5-60µg/ml. the % recovery was found to be 98-100%, the applicability of the method was examined by analysing the human plasma. The method was successfully applied for estimation of etomidate in pharmaceutical formulations.

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Sonkamble, Akhilkumar Gundu Dr. Satpute K. L. "Development and Validation of RP-HPLC Method for Simultaneous Estimation of Hydrochlorothiazide and Bisoprolol Fumarate in Pharmaceutical Dosage Form." International Journal of Pharmaceutical Sciences 2, no. 8 (2024): 2470–78. https://doi.org/10.5281/zenodo.13175222.

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A straightforward, focused, exact, and high-performance liquid chromatographic reverse phase approach was created for the simultaneous measurement of Hydrochlorothiazide and Bisoprolol Fumarate in tablet form. A 55:20:25 v/v/v mobile phase comprising TEA, acetonitrile, and methanol was employed in an isocratic mode Agilent. The effluent was measured at 225 nm, and the flow rate was 1 ml/min. Hydrochlorothiazide and Bisoprolol Fumarate had retention times of 3.79 and 9.71 minutes, respectively.

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Sonkamble, Akhilkumar Gundu* Dr. Satpute K. L. "Development and Validation of RP-HPLC Method for Simultaneous Estimation of Hydrochlorothiazide and Bisoprolol Fumarate in Pharmaceutical Dosage Form." International Journal of Pharmaceutical Sciences 2, no. 7 (2024): 2478–86. https://doi.org/10.5281/zenodo.13175668.

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A straightforward, focused, exact, and high-performance liquid chromatographic reverse phase approach was created for the simultaneous measurement of Hydrochlorothiazide and Bisoprolol Fumarate in tablet form. A 55:20:25 v/v/v mobile phase comprising TEA, acetonitrile, and methanol was employed in an isocratic mode Agilent. The effluent was measured at 225 nm, and the flow rate was 1 ml/min. Hydrochlorothiazide and Bisoprolol Fumarate had retention times of 3.79 and 9.71 minutes, respectively.

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

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

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Jyot, Gagan, and Balwinder Singh. "Development and Validation of an HPLC Method for Determination of Thiamethoxam and Its Metabolites in Cotton Leaves and Soil." Journal of AOAC INTERNATIONAL 100, no. 3 (2017): 796–803. http://dx.doi.org/10.5740/jaoacint.16-0206.

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Abstract An easy and simple analytical method was standardized and validated for the estimation of residues of thiamethoxam and its metabolites in cotton. The samples were extracted with acetonitrile, water, and methanol; diluted with brine solution;partitioned into dichloromethane and ethyl acetate; dried over anhydrous sodium sulfate; and cleaned up by glass column chromatography. Final clear extracts were concentrated under vacuum and reconstituted into HPLC grade acetonitrile, and residues were estimated using an HPLC instrument equipped with a C18 column and photodiode array detector syst

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Idowu, Olutosin R., Philip J. Kijak, Jeffery R. Meinertz, and Larry J. Schmidt. "Development and Validation of a Gas Chromatography/Mass Spectrometry Procedure for Confirmation of Para-Toluenesulfonamide in Edible Fish Fillet Tissue." Journal of AOAC INTERNATIONAL 87, no. 5 (2004): 1098–108. http://dx.doi.org/10.1093/jaoac/87.5.1098.

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Abstract Chloramine-T is a disinfectant being developed as a treatment for bacterial gill disease in cultured fish. As part of the drug approval process, a method is required for the confirmation of chloramine-T residues in edible fish tissue. The marker residue that will be used to determine the depletion of chloramine-T residues from the edible tissue of treated fish is para-toluenesulfonamide (p-TSA), a metabolite of chloramine-T. The development and validation of a procedure for the confirmation of p-TSA is described. Homogenized fish tissue is dried by mixing with anhydrous sodium sulfate

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Chadha, Renu, Alka Bali, and Gulshan Bansal. "Bioanalytical Method Validation for Dronedarone and Duloxetine in Blood Serum." Journal of AOAC INTERNATIONAL 100, no. 1 (2017): 45–50. http://dx.doi.org/10.5740/jaoacint.16-0204.

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Abstract The present work relates to the development and validation of reversed-phase HPLC–UV-photodiode array methods for the estimation of two drugs in blood serum: dronedarone hydrochloride (DDN), a class III antiarrhythmic drug, and duloxetine hydrochloride (DLX), an antidepressant. Chromatographic analysis of DLX was carried out on a Nucleodur C18 column (250 × 4.6 mm, 5 μm) using ammonium acetate buffer (32 mM, pH 5.5) and acetonitrile (40 + 60, v/v; flow rate of 1.0 mL/min; detection wavelength of 290 nm) as the mobile phase. A Waters XTerra C18 column (250 × 4.6 mm, 5 μm) was used for

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Sharmila, Dusia a. *. Ramanamma.L Prasad.DSVS. "METHOD DEVELOPMENT AND VALIDATION OF DONEPEZIL HYDROCHLORIDE BY RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 05 (2018): 4228–51. https://doi.org/10.5281/zenodo.1253713.

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A RP-HPLC for Donepezil hydrochloride in tablets was developed and validated. Donepezil hydrochloride is a reversible inhibitor of acetylcholinesterase, indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The HPLC method was performed with a unisol reversed phase C18 column (150×4.6 mm, 3 µm) detection at 268 nm and a mixture of Acetonitrile: Water (50:50) as mobile phase. Typical retention time for Donepezil was 4.407 mins. The method was statistically validated for linearity, accuracy, precision and selectivity following ICH recommendations. Due

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J., Kalpana, and Himaja M. "Simultaneous quantitation of corticosteroid drugs with their specified impurities using liquid chromatography." Journal of Indian Chemical Society Vol. 92, Apr 2015 (2015): 585–88. https://doi.org/10.5281/zenodo.5596996.

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Pharmaceutical Chemistry Division, School of Advanced Sciences, VIT University, Vellore-632 014, Tamilnadu, India <em>E-mail</em> : drmhimaja@gmail.com A rapid stability proving HPLC method was developed and validated for the estimation of the corticosteroid drugs in combination drug product. The chromatographic separation of betamethasone acetate and betamethasone sodium phosphate and five specified impurities were achieved with Hypersil BDS phenyl column (250 × 4.6 mm, 5 µm) with mobile phase consisting of water and acetonitrile (67 : 38 v/v) using 1 mL/min flow rate (UV detectio

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Dr., Sayyed Hussain, Amit Gosar Dr., Shaikh Tabrez, Sayyed Salim, and Mane V.G. "Determination of Genotoxic Impurity (R)-(+)-1-Phenylethylamine in Pregabalin Drug Substances by High Performance Liquid Chromatography." Trends in Pharmaceuticals and Nanotechnology 1, no. 1 (2019): 44–49. https://doi.org/10.5281/zenodo.2620640.

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<em>A highly sensitive high performance liquid chromatography (HPLC) method is developed and validated for the selective trace level determination of (R)-(+)-1-Phenylethylamine impurity, a potential genotoxic that may present in Pregabalin drug substances. HPLC column used was Prontosil 120-5-C18-ace-EPS (250 x 4.6 mm, 5µm). The gradient elution mode was selected where mobile phase-A consist of Buffer (40Mm Diammonium hydrogen o-phosphate solution adjusted to pH 6.5 with dilute orthophosphoric acid) and Methanol and Acetonitrile in ratio 8:1:1 while mobile phase-B as Acetonitrile, The fl

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Kasagić, Irena, Anđelija Malenović, Marko Jovanović, Tijana Rakić, Biljana Jančić Stojanović, and Darko Ivanović. "Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities." Acta Pharmaceutica 63, no. 2 (2013): 159–73. http://dx.doi.org/10.2478/acph-2013-0015.

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This paper presents the chemometrically assisted optimization and validation of the RP-HPLC method intended for the quantitative analysis of itraconazole and its impurities in pharmaceutical dosage forms. To reach the desired chromatographic resolution with a limited number of experiments in a minimum amount of time, Box- -Behnken design was used to simultaneously optimize some important chromatographic parameters, such as the acetonitrile content in the mobile phase, pH of the aqueous phase and the column temperature. Separation between itraconazole and impurity F was identified as critical a

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Singh, Balwinder, Kousik Mandal, Sanjay K. Sahoo, Urvashi Bhardwaj, and Raminderjit Singh Battu. "Development and Validation of an HPLC Method for Determination of Spirotetramat and Spirotetramat cis enol in Various Vegetables and Soil." Journal of AOAC INTERNATIONAL 96, no. 3 (2013): 670–75. http://dx.doi.org/10.5740/jaoacint.11-185.

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Abstract An easy and simple analytical method was standardized and validated for the estimation of residues of spirotetramat and its metabolite spirotetramat cis enol in various substrates: okra fruits, brinjal leaves and fruits, green chili, red chili, and soil. The samples were extracted with acetonitrile, diluted with brine solution, partitioned into dichloromethane, dried over anhydrous sodium sulfate, and cleaned up by treatment with activated charcoal powder. Final clear extracts were concentrated under vacuum and reconstituted with HPLC grade acetonitrile. Residues were estimated using

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V. Tathe, Shraddha, and Shivangi Gupta. "METHOD DEVELOPMENT AND VALIDATION OF FLURBIPROFEN SODIUM BY USING UPLC." Indian Drugs 60, no. 05 (2023): 102–4. http://dx.doi.org/10.53879/id.60.05.12864.

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A simple, precise, and accurate ultra-performance liquid chromatography was developed for flurbiprofen sodium on Acquity BEHC18, (50 x 2.1 mm, 1.7 µm) using acetonitrile: water: glacial acetic acid as the mobile phase. The flow rate was 0.2 mL min-1 and effluent was monitored at 254 nm. The retention time for flurbiprofen sodium was found to be 2.3. Developed method was validated for precision, accuracy, linearity range, robustness and ruggedness as per ICH guideline

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Pietruk, Konrad, and Piotr Jedziniak. "Determination of Ivermectin in Medicated Feeds by Liquid Chromatography with Fluorescence Detection." Scientific World Journal 2013 (2013): 1–5. http://dx.doi.org/10.1155/2013/362453.

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A labour- and time-effective analytical procedure for determination of ivermectin in medicated feed at recommended level of 2.0 mg kg−1has been developed and validated. The analyte was extracted from grinded feed samples with acetonitrile and derivatisated with N-methylimidazole and trifluoracetic anhydride. The fluorescent derivatives were analysed by liquid chromatography method using C8 column. The isocratic conditions using acetonitrile, methanol, water, and tetrahydrofuran were applied. Fluorescence detection was performed at 365 nm (excitation) and 475 nm (emission) wavelengths. The tota

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Azka, fathima *and Shaik Gazi. "METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF CAPECITABINE BY RP-HPLC METHOD." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7808–14. https://doi.org/10.5281/zenodo.1402154.

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<em>A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Capecitabine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6×150mm, 5µm) column using a mixture of Acetonitrile: Water (50:50v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 245 nm. The retention time of the Capecitabine was 2.4 ±0.02min. The method produce linear responses in the concentration range of 15-75mg/ml of Capecitabine. The method precision for th

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

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

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G., Sirisha* M. Gayathri Devi M. Gowri Manoja G. Sudhakar. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TRABECTEDIN IN BULK AND PARENTERAL DOSAGE FORM BY RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 03 (2018): 1642–48. https://doi.org/10.5281/zenodo.1208619.

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A new RP-HPLC method for the quantitative determination of Trabectedin was developed and validated as per ICH guidelines. The drugs were injected into Zorbax SB, C18,(150x4.6mm); 3.5µm column maintained at ambient temperature and effluent monitored at 215nm. The mobile phase consisted of phosphate buffer (pH 3.0) and Acetonitrile in the ratio of 70:30 V/V. The flow rate was maintained at 0.8 ml/min. The calibration curve for Trabectedin was linear from 50-175µg/ml (r 2 for Trabectedin = 1 ). The proposed method was adequate, sensitive, reproducible, accurate and precise for the det

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Vijey Aanandhi M, Elancheziyan K, Yamini R, Prakash Chand T, Aysha Jadeera K A, and Binoy Varghese Cheriyan. "Method Development and Validation of Fludrocortisone Acetate Tablets by Reverse Phase HPLC Method." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 6826–33. http://dx.doi.org/10.26452/ijrps.v11i4.3652.

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The purpose or intent of this current study was to establish a fast and sensitive HPLC technique for the perseverance of Fludrocortisone acetate and utilizing best frequently used HPLC technique. This method had been validated as per the ICH requirements to assure that the method consistently meets the predetermined specifications and quality attributes.Utilizing filtered and degassed pH 3.0 Phosphate buffer and Acetonitrile in the ratio 90:10 as a Mobile phase-A and pH 3.0 Phosphate buffer and Acetonitrile in the ratio 65:35 as a Mobile phase-B the established RP-HPLC technique was done. The

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Horyn, Mariana, and Liliya Logoyda. "Bioanalytical method development and validation for the determination of metoprolol and meldonium in human plasma." Pharmacia 67, no. (2) (2020): 39–48. https://doi.org/10.3897/pharmacia.67.e50397.

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Aim.The main purpose of this study was to develop a simple, precise, rapid and accurate method for the quantification of metoprolol and meldonium in human plasma. Materials and methods. The resolution of peaks of metoprolol was best achieved with Discovery C18, 50 × 2.1 mm, 5 μm column and meldonium - ZORBAX HILIC Plus, 50 × 2.1 mm, 3.5 μm column. Samples of metoprolol were chromatographed in a gradient mode (eluent A (acetonitrile – water – formic acid, 5 : 95 : 0.1 v/v), eluent B (acetonitrile – formic acid, 100 : 0.1 v/v)). The initial content of the eluent B is 0%, which increases linearly

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Pietro, Wojciech Jerzy, Aneta Woźniak, Katarzyna Pasik, Wojciech Cybulski, and Dorota Krasucka. "Amphenicols stability in medicated feed – development and validation of liquid chromatography method." Bulletin of the Veterinary Institute in Pulawy 58, no. 4 (2014): 621–29. http://dx.doi.org/10.2478/bvip-2014-0095.

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Abstract A liquid chromatography-ultraviolet detection method for the determination of florfenicol (FF) and thiamphenicol (TAP) in feeds is presented. The method comprises the extraction of analytes from the matrix with a mixture of methanol and acetonitrile, drying of the extract, and its dissolution in phosphate buffer. The analysis was performed with a gradient programme of the mobile phase composed of acetonitrile and buffer (pH = 7.3) on a Zorbax Eclipse Plus C18 (150 × 4.6 mm, 5 μm) analytical column with UV (λ = 220 nm) detection. The analytical procedure has been successfully adopted a

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Rajkumar, Prava*1 Ganapathy seru Jayapal Reddy Sama Arun Satyadev Sidhhanadham. "CHIRAL LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR SEPERATION OF PHENIRAMINE ENANTIOMERS." iajps,csk publications 03, no. 12 (2017): 1521–33. https://doi.org/10.5281/zenodo.228175.

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Pheniramine is an antihistamine with anticholinergic properties used to treat allergic conditions such as hay fever or urticaria. It has relatively strong sedative effects, and may sometimes be used off-label as an over-the-counter sleeping pill in a similar manner to other sedating antihistamines such as diphenhydramine. Pheniramine is also commonly found in eyedrops used for the treatment of allergic conjunctivitis. According to literature survey there is no method reported for the seperation of Pheniramine enantiomers by RP-HPLC in pharmaceutical dosage forms. This present research work mai

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M., Gayathri Devi* K. Maanasa M. Gowri Manoja. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF METFORMIN AND VOGLIBOSE IN BULK AND FIXED DOSE COMBINATION (TABLETS) BY RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 02 (2018): 825–31. https://doi.org/10.5281/zenodo.1174325.

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A new RP-HPLC method for the quantitative determination of Metformin and Voglibose was developed and validated as per ICH guidelines. The drugs were injected into Hypersil BDS C18 column (250×4.6, 5 µm), maintained at ambient temperature and effluent monitored at 236 nm.The mobile phase consisted of 0.02M KH2PO4: Acetonitrile (50:50 V/V). The flow rate was maintained at 1.0 ml/min. The calibration curve for Metformin and Voglibose were linear from 50-300µg/ml and 0.3-0.18µg/ml respectively (r2 for Metformin = 0.997,r 2 for Voglibose = 0.998).The proposed method was adeq

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B., Prasanthi* M. Gayathri Devi P. V. Madhavi Latha. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF METFORMIN AND SITAGLIPTIN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 02 (2018): 882–89. https://doi.org/10.5281/zenodo.1181449.

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A new RP-HPLC method for the quantitative determination of Metformin and Sitagliptin was developed and validated as per ICH guidelines. The drugs were injected into Kromasil C18 (4.6 x 250mm, 5µm), maintained at ambient temperature and effluent monitored at 254 nm.The mobile phase consisted of OPA (0.1%) : Acetonitrile (40% : 60% ) The flow rate was maintained at 1.0 ml/min. The calibration curve for Metformin and Sitagliptin were linear from 125-7500µg/ml and 12.5-75µg/ml respectively (r2 for Metformin = 0.999,r2 for Sitagliptin = 0.999).The proposed method was adequate, sen

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Harahap, Yahdiana, and Innet Maysyarah. "ANALYTICAL VALIDATION OF CLOPIDOGREL IN HUMAN PLASMA THROUGH ULTRAHIGHPERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY." International Journal of Applied Pharmaceutics 9 (October 30, 2017): 163. http://dx.doi.org/10.22159/ijap.2017.v9s1.79_86.

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Objective: This study developed a sensitive, selective, and valid method for analyzing clopidogrel in human plasma using liquid chromatographytandemmass spectrometry (LC-MS/MS).Methods: The chromatography separation was performed on the waters ACQUITY UPLC Class BEH C18 1.7 μm (2.1 × 100 mm) column, consisting of0.1% formic acid in water and 0.1% formic acid in acetonitrile (30-70) as the mobile phase, and an isocratic elution with a flow rate of 0.2 mL/minutes.The mass detection was performed using a Waters Xevo TQD equipped with positive electrospray ionization in the multiple reaction monit

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Wulandari, Lestyo. "DETERMINATION AND VALIDATION OF MEBHYDROLINE NAPADISYLATE IN TABLETS BY HPLC." Indonesian Journal of Chemistry 8, no. 3 (2010): 377–79. http://dx.doi.org/10.22146/ijc.21610.

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An accurate and sensitive HPLC method has been developed for the determination of mebhydroline napadisylate in the tablet. The Chromatography was performed on a reversed phase C-18 column, using a mobile phase of acetonitrile : ammonia 25% (80 : 20 v/v) at ambient temperature 25±5 °C and UV detection operates at 320 nm in an overall analysis time of about 15 min, based on peak area. This HPLC method is selective, precise, and accurate and can be used for routine analysis of pharmaceutical preparation in industrial quality-control laboratories. Keywords : HPLC, mebhydroline napadisylate, valida

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Rameshpetchi, Rajendran Devikasubramaniyan* Ramya Sri Sura M. Praveen Kumar L.Soundharya M. Arun Kumar M. Sumalatha. "ESTIMATION OF ENTECAVIR IN PURE AND PHARMACEUTICAL FORMULATION BY USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2073–79. https://doi.org/10.5281/zenodo.1214531.

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A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Entecavir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6 x 250mm, 5µm) column using a mixture of Acetonitrile and Water (15:85% v/v) as the mobile phase at a flow rate of 0.9ml/min, the detection was carried out at 215nm. The retention time of the Entecavir was 3.1 ±0.02min. The method produce linear responses in the concentration range of 30-150µg/ml of Entecavir. The method precision for

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Rameshpetchi, Rajendran Devikasubramaniyan* Ramya Sri Sura Ch.Brammam G.Shyamala J.Swarna J.Akhil K.Sunajani. "VALIDATED RP-HPLC METHOD FOR ESTIMATION OF GRANISETRON IN API AND DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2080–87. https://doi.org/10.5281/zenodo.1214533.

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A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Granisetron, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 250mm, 5µm) column using a mixture of Acetonitrile and Water (50:50% v/v) as the mobile phase at a flow rate of 0.8ml/min, the detection was carried out at 285nm. The retention time of the Granisetron was 3.0 ±0.02min. The method produce linear responses in the concentration range of 20-100µg/ml of Granisetron. The method precision for th

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Harshith Kumar R, Abhishek K, and Rakesh Kumar Jat. "Development and Validation of Bioanalytical Method for Simultaneous Quantification of Anti-Hypertensive Drugs by Using HPLC." Tropical Journal of Pharmaceutical and Life Sciences 11, no. 5 (2024): 32–41. https://doi.org/10.61280/tjpls.v11i5.166.

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The chromatographic separation was achieved by using eclipse plus C8 (250mm x 4.6mm, 5μm) column by applying isocratic elution using the mobile phase Ⅰ consist of (methanol + acetonitrile 60:40 v/v) and mobile phase Ⅱ consist of (water with 0.01% of diethyl amine) in the ratio 80: 20 (v/v) detection was carried at the 225 nm by employing 1ml/min flow rate. The separation of drugs from the plasma was achieved using protein precipitation technique by acetonitrile. The retention time was found to be 6.573 min and 5.421 min for metoprolol succinate and cilnidipine respectively. The developed metho

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Klimenko, L. Yu, V. S. Bondar, and O. V. Gumeniuk. "Development and validation of the methods of phenytoin determination in urine by the method of gas–liquid chromatography." Farmatsevtychnyi zhurnal, no. 1 (February 12, 2019): 96–104. http://dx.doi.org/10.32352/0367-3057.1.15.07.

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Development of the methods of strong medicines determination in human biological liquids for application in forensic and clinical toxicology is one of actual problems of pharmaceutical science, but validation of the analytical methods becomes much more vital and widely discussed problem in analytical toxicology in the last decade. The purpose of the paper was to develop the methods of phenytoin quantitative determination in urine based on the offered before procedure of the analyte determination by the method of gas–liquid chromatography and to carry out validation of the developed metho

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Mrs., Kansa Noori* G. . Narendar CH. Anjali G. Srilatha B. Vani Santosh Illendula K.N.V. Rao K. Rajeswar Dutt. "METHOD DEVELOPMENT AND VALIDATION OF PROPRANOLOL HCL BY UV SPECTROSCOPIC METHOD IN A BULK AND PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 04 (2019): 7015–21. https://doi.org/10.5281/zenodo.2628126.

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<em>A new simple, accurate, rapid, precise, reproducible and cost-effective spectrophotometric method for the quantitative estimation of Propranolol Hcl in bulk and pharmaceutical dosage form. The developed UV spectrophotometric method for the quantitative estimation of Propranolol Hcl is based on measurement of absorption at maximum wavelength 228 nm using Acetonitrile with buffer as a solvent. The stock solution of Propranolol Hcl was prepared, and subsequent suitable dilution was prepared in acetonitrile: buffer to obtained standard curve. The standard solution of Propranolol Hcl shows abso

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Jin, Liang Jie, Cheng Hong Liang, Yong Zhang, and Zhi Yong Li. "HPLC Method for Bacillamide C Analysis in the Metabolites of a Bacillus atrophaeus Strain." Advanced Materials Research 926-930 (May 2014): 1001–4. http://dx.doi.org/10.4028/www.scientific.net/amr.926-930.1001.

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A new HPLC method for the analysis of bacillamide C, with DAD detector at 220nm, has been developed, validated and used in the EtOAC extracts of the fermentation broth of a Bacillus atrophaeus strain, associated with the South China Sea sponge Dysidea avara. Bacillamide C was well quantified on a reversed phase ZORBAX Eclipse XDB-C18 column by use of a gradient mobile phase from 20% (v/v) acetonitrile to 45% (v/v) acetonitrile in 15 min at a flow rate of 1 mL/min. The linearity ranges were 1.00-1000.00μg/mL with values of LOD (limit of detection) equal to 0.15μg/mL. The HPLC method was proved

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M., Sunil, Ramanjaneyulu A., Harshavardhan A., Suvarna Raj P., Manikya Bai N., and Aswani T. "Determination, Development and Validation of Method for Simultaneous AXITINIB Pharmaceutical Dosage form by a Reverse Phase HPLC." Research & Review: Drugs and Drugs Development 1, no. 2 (2019): 28–42. https://doi.org/10.5281/zenodo.3227877.

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<em>A simple and selective LC method is described for the determination of AXITINIB dosage forms. Chromatographic separation is observed on a c<sub>18</sub> packing column using mobile phase with a mixture of TEA -Acetonitrile (50:50) with detected at 254nm. Linearity was observed in the range 15-45 µg /ml for AXITINIB (r<sup>2</sup> =0.997) for drug estimated by the proposed methods was in good agreement with the label claim. The proposed method was validated. The accuracy of the methods was assessed by recovery studies at three different levels. The current study indicated the absence

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Lurdhu, Mary1 Grandhi Surendra2 Harshitha Reddy3 Shaik Uzma Aafreen4 N. Kusuma5 P. Hari Chandana6 Mohana Kollipara7 D. Maha Lakshmi8 K. Lalitha9 CH K. V. L. S. N. Anjana Male*10. "Method Development and Method Validation of Daprodustat - Using Reverse phase High Performance Liquid Chromatography Method." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3314–23. https://doi.org/10.5281/zenodo.15303482.

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Aim: Daprodustat in pharmaceutical dosage forms has been previously analyzed quantitatively using reverse-phase high-performance liquid chromatography (RP-HPLC) approach that was easy to use, quick, accurate, sensitive, and repeatable. Materials and methods: Daprodustat was separated chromatographically using a Waters Alliance e2695 system and a Waters X-Terra RP-18 column (150x4.6mm, 3.5µ). The mobile phase was made up of 50% v/v ACN and HSA pH-2.5/OPA. Photodiode array detector was operated at room temperature is utilized to detect absorption at 235 nanometers while the flowrate was fi

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

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

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B.Rajkamal*and, Yadamma. "VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ESTIMATION OF NELFINAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM." Indo American Journal of Pharmaceutical Sciences 05, no. 06 (2018): 5547–52. https://doi.org/10.5281/zenodo.1296991.

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<em>A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Nelfinavir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Zorbax C18 (4.6 x 250mm, 5µm) column using a mixture of Acetonitrile and Water (15:85% v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 218nm. The retention time of the Nelfinavir was 5.430</em> <em>±0.02min. The method produce linear responses in the concentration range of 10-50ppm of Nelfinavir. The method precision for t

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Notario, Dion, Aprillia Suwita, and Kelviyana Kelviyana. "Analytical Method Validation of Sulfamethoxazole in Human Plasma and Urine by HPLC-PDA." Jurnal Sains dan Kesehatan 4, SE-1 (2022): 31–38. http://dx.doi.org/10.25026/jsk.v4ise-1.1687.

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An analytical method for analyzing SMZ in human plasma and urine using high-performance liquid chromatography (HPLC) was developed. The separation was carried out on a Shim-pack GIST® C18 column (150 × 4.6 mm, 5 ?m) with a temperature setting of 30°C. The mobile phase consisted of glacial acetic acid pH 2.5: methanol: acetonitrile (70:25:5, v/v/v) at a rate of 0.8 mL/min. Detection was done using a PDA detector in the range of ?190-800 nm, and quantification was carried out at ?265 nm. Plasma sample preparation used the protein precipitation method with acetonitrile as the precipitating solven

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Lal, Basant, Manish Jaimini, and Devesh Kapoor. "Development and Validation of a RP-HPLC Method for the Simultaneous estimation of Amoxicillin, Omeprazole and Tinidazole in fixed dose combinations." Journal of Drug Delivery and Therapeutics 11, no. 5-S (2021): 57–62. http://dx.doi.org/10.22270/jddt.v11i5-s.5020.

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New liquid chromatographic technique was established for the simultaneous estimation of tinidazole, omeprazole and amoxicillin in the fixed dose combination (HP-KIT by Sun Pharma). RP-HPLC elution has performed by using the Phenomenex Luna column (250 mm x 4.6 mm) having internal diameter and the packing material of size 5µm) in isocratic mobile phase of solution A: acetonitrile at a ratio of 80:20 v/v (Solution A consists of Buffer: Acetonitrile: Methanol: Triethylamine in the ratios of 68:22:10:0.01 respectively). The selected flow rate was kept as 1 ml/min and selected wavelength was 230 nm

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Kozin, D. A., N. Yu Kulbachevskaya, V. A. Balykov, and Z. S. Shprakh. "Development and validation of bioanalytical technique for the LCS-1269 assay by high-performance liquid chromatography." Russian Journal of Biotherapy 24, no. 2 (2025): 73–82. https://doi.org/10.17650/1726-9784-2025-24-2-73-82.

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Background. The glycosylated derivative of indolo[2,3-a]carbazole LCS-1269, an DNA intercalator and a chromatin remodulator, synthesized in N.N. Blokhin National Medical Research Center of Oncology (N.N. Blokhin NMRCO), is of great interest for the treatment of malignant tumors. To carry out pharmacokinetic studies of LCS-1269 dosage forms in vivo, it is necessary to develop a method for LCS-1269 assay in biological samples.Aim. To develop and validate an analytical technique using high-performance liquid chromatography with ultraviolet detection (HPLC-UV) for LCS-1269 pharmacokinetic studies.

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Avram, Nicolae, Simona Codruta Heghes, Luca-Liviu Rus, et al. "HPLC-UV Determination of Dextromethorphan in Syrup Method validation." Revista de Chimie 70, no. 2 (2019): 487–90. http://dx.doi.org/10.37358/rc.19.2.6940.

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A HPLC-UV method, for determination of dextromethorphan hydrobromide in syrup, was validated. The chromatographic analysis was performed using an RP-18, Nucleodur chromatographic column (250 mm � 4 mm, 5 �m) at constant temperature (50oC) with a mobile phase consisting of a mixture of acetonitrile/methanol (70:30 v/v) with sodium docusate (as ion pair agent) and ammonium nitrate, pH = 3.4. The flow rate of the mobile phase was 1 mL/min and the detection was carried out at 280 nm. System suitability, specificity, linearity, precision, accuracy, limit of detection and limit of quantification agr

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B., Rama Rao a. *. V. Venkata Rao b. B.S. Venkateswarlu c. "DEVELOPMENT AND VALIDATION OF REVERSED-PHASE HPLC ISOCRATIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF LESINURAD AND ALLOPURINOL." Journal of Pharma Research 7, no. 11 (2018): 257–60. https://doi.org/10.5281/zenodo.1789458.

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<strong><em>ABSTRACT</em></strong> <strong><em>A</em></strong><em>n isocratic reversed-phase liquid chromatograpic assay method was developed for the quantitative determination of Lesinurad and Allopurinol. A Inetsil C-18, 5 µm column with a mobile phase containing </em><em>Acetonitrile: Methanol: 0.1% Triethylamine buffer (pH-adjusted to 3 using o-phosphoric acid) 25:35:40 (v/v/v). The flow rate was 1.0 mL/min and effluents were monitored at 250 nm. The retention times of oxycodone and naltrexone were 5.57 min and 2.60min, respectively. The proposed method was validated with respect to

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