scholarly journals Validated Stability Indicating Chromatographic Method for the Simultaneous Estimation of Camylofin with NSAID Drugs and a New Approach of Method Transfer from Classical HPLC to a Modern UPLC Instrument

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Sheetal Makwana ◽  
Madhavi Patel ◽  
Devang Prajapati ◽  
Chandni Shingala ◽  
Jatin Upadhyay ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Retention Time ◽  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Correlation Coefficients ◽  
Accurate Method ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Combination Tablet

The presented work describes the method development of simultaneous determination of camylofin dihydrochloride (CMF), diclofenac potassium (DCF), and Paracetamol (PCM) using reversed phase high performance liquid chromatography (HPLC-UV) and the method was further transferred to a new generation instrument, ultraperformance liquid chromatography (UPLC-PDA). The detailed validation was carried out for the combination tablet formulation of CMF and DCF by UPLC-PDA. From the method development study, Acquity UPLC HSS C18 (2.1 × 50 mm, 1.8 μm) was finally selected for validation. The satisfactory results were observed for peak shape, retention time, and resolution with a mobile phase of 20 mM ammonium acetate buffer (pH 3.0 with dilute orthophosphoric acid) : methanol (33 : 67 v/v). The isocratic elution of mobile phase was carried out at a flow rate of 0.250 mL/min and detection at 220 nm. Both drugs were efficiently separated out in less than 3.5 min with 1.1 and 3.2 min of retention time of the CMF and DCF with 11.87 of resolution. The linearity was obtained in the 20.0–80.0 μg/mL range of concentration with 0.9998 of correlation coefficients for the substances. The method was analyzed for specificity with detailed force degradation study, which is a simple, precise, and accurate method, as per the International Conference on Harmonization (ICH) guidelines.

scholarly journals RP-HPLC method development and validation for simultaneous estimation of efonidipine hydrochloride ethanolate and telmisartan in their synthetic mixture

2021 ◽  
pp. 190-195
Author(s):  
Grishma H Patel ◽  
Shreya D Adeshra ◽  
Dhananjay B Meshram
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Quality Control Laboratory ◽  
Efficient Option ◽  
Liquid Chromatographic

A Novel, selective, accurate and rapid Reversed Phase High Performance Liquid Chromatographic (RPHPLC) method for the analysis of Efonidipine Hydrochloride Ethanolate and Telmisartan in binary mixture has been developed and validated. The chromatographic system consisted of a Phenomenex Kinetex ® 5µ C18 Size: 150 * 4.6mm column and the separation was achieved by using ambient temperature with a mobile phase containing mobile Phase Acetonitrile:25mM Phosphate Buffer pH 4.9 (45:55). The samples were monitored at 253 nm for detection at a flow rate of 1.0 mL/min and the retention time was about 7.77 and 4.10 mins for Efonidipine Hydrochloride Ehanolate and Telmisartan respectively. The calibration curve was linear over the concentration range 5-30 and 10-60 ?g/mL for Efonidipine Hydrochloride Ehanolate and Telmisartan respectively. The proposed method is accurate in the range of 99.75% - 100.10% recovery and precise (%RSD of intraday variation and % RSD of inter day variation were found to be within the acceptance criteria). Therefore, this method can be used as a more convenient and efficient option for the analysis of Efonidipine Hydrochloride Ehanolate and Telmisartan in Quality control laboratory.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR BY REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND TABLET DOSAGE FORMS

2017 ◽  
Vol 10 (11) ◽  
pp. 59
Author(s):  
Sufiyan Ahmad ◽  
Mohammed Rageeb Mohammed Usman
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

  Objective: A simple rapid, accurate, precise, and reproducible validated reversed-phase high performance liquid chromatography method was developed for the determination of emtricitabine (EMB) and tenofovir (TEN) in bulk and tablet dosage forms.Methods: The quantification was carried out using symmetry Premsil C18 (250 mm×4.6 mm, 5 μm) Younglin (S.K.) gradient way using mobile phase comprising of methanol:water (70:30 v/v) pH 3 and a detection wavelength of 273 nm, and injection volume of 20 μL, with a flow rate of 1 ml/minutes.Results: In the developed method, the retention time of EMB and TEN were found to be 3.1667 minutes and 7.5000 minutes. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines.Conclusion: The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible. Hence, it is worthwhile that the proposed methods can be successfully utilized for the routine quality control analysis EMB and TEN in bulk drug as well as in formulations.

scholarly journals Method Development and Its Validation for Simultaneous Estimation of Domperidone and Esomeprazole by RP-HPLC in Combination Tablet Dosage Form

2016 ◽  
Vol 1 (01) ◽  
pp. 46-55
Author(s):  
V. Tejasvi Reddy ◽  
S. Hari Hara Kumar ◽  
M Akiful Haque ◽  
Vasudha Bakshi
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Correlation Coefficients ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Limit Of Quantification ◽  
Combination Tablet ◽  
Rp Hplc

A simple and validated reverse phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneous estimation of Esomeprazole and Domperidone. Different HPLC Chromatographic conditions were used to find out the optimum chromatographic condition for best elution of drugs. Good chromatographic separation was achieved on Develosil ODS HG-5 RP C18 (15cmX4.6mm, 5m Particle size), analytical column using a mixture of Potassium dihydrogen phosphate buffer pH: acetonitrile in the ratio of 45:55 v/v used as mobile phase at the flow rate of 1 ml/min and detector wavelength at 284nm. The validation of the proposed method was carried out for specificity, linearity and range, accuracy, precision, limit of detection and limit of quantification. Linearity range was found to be 0-140 μg/ml and 0-150 μg/ml with correlation coefficients of 0.995 and 0.994 and retention time of 2.59 and 3.85 min for Domperidone and Esomeprazole respectively. The LOD was found to be 0.341 g/ml and 2.031 g/ml and LOQ was found to be 1.023 g/ml and 6.093 g/ml respectively. The result shows the developed method is yet another suitable method for assay and stability studies which can help in the analysis of Domperidone and Esomeprazole in different formulations.

scholarly journals Development of a new analytical method for determination of acetylsalicylic and salicylic acids in tablets by reversed phase liquid chromatography

2009 ◽  
Vol 45 (4) ◽  
pp. 723-727 ◽  
Author(s):  
José Luiz Neves de Aguiar ◽  
Katia Christina Leandro ◽  
Shirley de Mello Pereira Abrantes ◽  
André Luis Mazzei Albert
Keyword(s):  
Liquid Chromatography ◽  
High Performance ◽  
Correlation Coefficients ◽  
High Sensitivity ◽  
Accurate Method ◽  
Reversed Phase ◽  
United States Pharmacopoeia ◽  
Phase Liquid ◽  
Salicylic Acids

Acetylsalicylic acid (AAS) is a drug utilized as analgesic, anti-inflammatory, and antipyretic medication, available worldwide and commonly used in Brazil. Salicylic acid (AS) is a precursor in AAS synthesis and is also produced during its degradation. The official United States Pharmacopoeia (USP) suggests the determination of these drugs by high performance liquid chromatography (HPLC), with ultraviolet detection, but this method has neither a high sensitivity (S AAS=0.12 mAbs/(μg/mL) and S AS=0.48 mAbs/(μg/mL)) nor resolution (Rs=1.61). The purpose of this study was to develop a new more adequate, accurate method by liquid phase chromatography than the current official methodology, and to use this new method in the determination of the tenors of acetylsalicylic, as of salicylic acids in tablets. The parameters of the chromatographic system for both the AAS and AS were satisfactory. Selectivity was verified by absorption spectra comparison in the ultraviolet (UV) range, during and after substance retention time. The linear range for AAS was 0.21 to 0.39 mg/mL, and that for AS was 6.3 to 11.7 μg/mL. The correlation coefficients (r) of the analytical curves of AAS and AS were 0.9995 and 0.9988, respectively; and the detection and quantification limits for the AS were 0.23 and 0.69 μg/mL. The sensitivity (S AAS=1.88 mAbs/(μg/mL) and S AS=1.84 mAbs/(μg/mL)) and the resolution (Rs =5.06) show the improvement obtained using this method over that described by the USP.

scholarly journals Method Development and Validation for Simultaneous Estimation of Ketorolac and Sparfloxacin by RP-HPLC

2013 ◽  
Vol 1 (04) ◽  
pp. 95-101 ◽  
Author(s):  
Rahul Singh ◽  
Ashish Pathak ◽  
Pooja Chawla
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Sample Volume ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Mobile Phase Flow Rate ◽  
Pharmaceutical Dosage Forms ◽  
Liquid Chromatography Method

A modified simple, selective, rapid, precise reversed phase high performance liquid chromatography method has been developed and validated for the simultaneous estimation of ketorolac and sparfloxacin. The separation was made in a Hypersil-Keystone C-18 column using a methanol: water (60:40, v/v) (pH 3.1) as mobile phase at 308 nm. The mobile-phase flow rate and the sample volume injected were 0.9 ml/min and 20 μl, respectively. Retention time of sparfloxacin and ketorolac was found to be 3.181 and 4.473 minutes respectively. The correlation coefficient of both drugs was found to be 0.999. The accuracy of ketorolac was found to be 99.82% - 100.55% whereas for sparfloxacin, it was 99.76% - 99.89%. Over all % RSD was found to be less than 2%. The method was validated according to ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, etc. The developed method can be used for routine analysis of ketorolac and sparfloxacin in their pharmaceutical dosage forms.

scholarly journals Method Development and Its Validation for Simultaneous Estimation of Domperidone and Esomeprazole by RP-HPLC in Combination Tablet Dosage Form

2016 ◽  
Vol 1 (1) ◽  
Author(s):  
V. Tejasvi Reddy ◽  
S. Hari Hara Kumar ◽  
M Akiful Haque ◽  
Dr. Vasudha Bakshi
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Correlation Coefficients ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Limit Of Quantification ◽  
Combination Tablet ◽  
Rp Hplc

A simple and validated reverse phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneous estimation of Esomeprazole and Domperidone. Different HPLC Chromatographic conditions were used to find out the optimum chromatographic condition for best elution of drugs. Good chromatographic separation was achieved on Develosil ODS HG-5 RP C18 (15cmX4.6mm, 5μm Particle size), analytical column using a mixture of Potassium dihydrogen phosphate buffer pH: acetonitrile in the ratio of 45:55 v/v used as mobile phase at the flow rate of 1 ml/min and detector wavelength at 284nm. The validation of the proposed method was carried out for specificity, linearity and range, accuracy, precision, limit of detection and limit of quantification. Linearity range was found to be 0-140 μgg/ml and 0-150 μgg/ml with correlation coefficients of 0.995 & 0.994 and retention time of 2.59 and 3.85 min for Domperidone and Esomeprazole respectively. The LOD was found to be 0.341 μg/ml and 2.031 μg/ml and LOQ was found to be 1.023 μg/ml and 6.093 μg/ml respectively. The result shows the developed method is yet another suitable method for assay and stability studies which can help in the analysis of Domperidone & Esomeprazole in different formulations.

scholarly journals REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DICYCLOMINE HYDROCHLORIDE, PARACETAMOL AND MEFENAMIC ACID IN BULK AND TABLET DOSAGE FORM

2017 ◽  
Vol 10 (3) ◽  
pp. 393
Author(s):  
Janhavi R Rao ◽  
Esha Khadge ◽  
Savita Yadav
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Mefenamic Acid ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Chromatography Method ◽  
Tablet Dosage

ABSTRACTObjective: The objective of this study was to develop and validate a simple, precise and accurate reverse phase high performance liquid chromatographicmethod for simultaneous estimation of dicyclomine hydrochloride, paracetamol, and mefenamic acid from multicomponent tablet dosage form.Methods: The optimized chromatographic separation was achieved using a stationary phase of hypersil gold ODS- C18 (250 × 4.6 mm i.d, 5 μmparticle size) column and mobile phase of acetonitrile: Methanol: Potassium dihydrogen phosphate buffer, pH adjusted to 4.5 with orthophosphoricacid (OPA) in the ratio of 50: 30: 20 (v/v/v) with a flow rate of 1 mL/minute. The ultraviolet detection was carried out at 260 nm.Results: The retention times of paracetamol, dicyclomine hydrochloride and MEF were found to be 4.2, 6.1 and 3.4 minutes, respectively. The methodwas validated for linearity, precision, accuracy, and robustness. The developed method provided linear responses within the concentration ranges2-12 μg/mL for dicyclomine hydrochloride, 50-300 μg/mL for paracetamol, and 25-150 μg/mL for MEF. The % recovery obtained were found to be99.09-99.44% for dicyclomine hydrochloride, 99.22-99.51% for paracetamol, and 99.49-99.60 for MEF.Conclusion: The proposed method enables rapid quantification and simultaneous analysis of all the drugs from commercial formulations without anyinterference of excipients. Hence, the developed method can be successfully applied for routine analysis of dicyclomine hydrochloride, paracetamol,and MEF in their combined tablet formulation.Keywords: Dicyclomine hydrochloride, Paracetamol, Mefenamic acid, High performance liquid chromatography

scholarly journals SIMULTANEOUS IDENTIFICATION AND QUANTIFICATION OF HYDROQUINONE, TRETINOIN AND BETAMETHASONE IN COSMETIC PRODUCTS BY ISOCRATIC REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

2019 ◽  
pp. 181-185 ◽  
Author(s):  
Baitha Maggadani ◽  
Harmita Harmita ◽  
Yahdiana Harahap ◽  
Hanna Hutabalian
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Flow Rate ◽  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Two Samples ◽  
Simultaneous Identification

Objective: The objective of this study was to obtain a simple and selective analysis method for determination of hydroquinone, tretinoin and betamethasone in whitening creams using reversed phase high-performance liquid chromatography (HPLC). Methods: Reverse Phase HPLC was used for method development, validation studies, and sample analysis. The method was optimized by evaluating several parameters that affects extraction of the sample, composition and types of mobile phase and also flow rate. Chromatographic separation was optimized on a C18 column [Sunfire, 250 x 4.6 mm, 5µm] utilizing a mobile phase consisting acetonitrile, methanol (90:10 v/v) and slightly addition of glacial acetic acid to reach pH 5in the ratio of 30: 50:20 v/v at a flow rate of 0.8 ml/min with UV detection at 270 nm and 350 nm. Results: The analytical methods fulfilled the validation requirements including accuracy, precision, linearity, selectivity, detection limits, and quantitation limits. The results showed the mean levels of hydroquinone, tretinoin and betamethasone in samples A and B were 1.78%; 0.07%; 0.12% and 2.00%; 0.07%; 0.13% respectively. Conclusion: The method was successfully applied for the determination of cosmetic formulation containing hydroquinone, tretinoin and betamethasone simultaneously. There were seven samples analyzed and two samples were positive containing hydroquinone, tretinoin, and betamethasone.

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