scholarly journals Method Development and Validation for Simultaneous Estimation of Benidipine Hydrochloride and Metoprolol Succinate in Tablet

2019 ◽  
Vol 9 (6-s) ◽  
pp. 28-33
Author(s):  
Dhaval M Patel ◽  
Deepa Patel ◽  
Advaita Patel ◽  
Avani Sheth ◽  
Utsav J Shah

Present work focusing in developing and validating a new high performance liquid chromatography method for estimation of Metoprolol Succinate and Benidipine Hydrochloride in their combine tablet dosage form. The method was performed on Shimadzu LC-20AT instrument using C18 (250 mm x 4.6 mm, 5 µm) Hypersil BDS Column and Potassium Dihydrogen Phosphate Buffer (pH 4.0): Methanol (65: 35% v/v) as mobile phase at ambient temperature. Detection was carried out at 269 nm. Concentration range 4-12 µg/ml for Benidipine Hydrochloride and 25-75 µg/ml for Metoprolol Succinate . The Percentage recovery of Benidipine Hydrochloride and Metoprrolol succinate was found to be 99.59% and 99.39 respectively. Correlation coefficient for Metoprolol succinate and Benidipine Hydrochloride was found 0.9995 and 0.9997 respectively. The Rt values for Metoprolol succinate and Benidipine Hydrochloride were found to be 3.4 and 5.9 min respectively. The method was validated according to the guidelines of International Conference on Harmonisation (ICH) and was successfully employed in the estimation of commercial formulations. Keywords:  Metoprolol Succinate, Benidipine Hydrochoride, HPLC, Mobile Phase,

2013 ◽  
Vol 1 (04) ◽  
pp. 95-101 ◽  
Author(s):  
Rahul Singh ◽  
Ashish Pathak ◽  
Pooja Chawla

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.


2007 ◽  
Vol 90 (6) ◽  
pp. 1573-1578 ◽  
Author(s):  
Charmy R Shah ◽  
Nehal J Shah ◽  
Bhanubhai N Suhagia ◽  
Natvarlal M Patel

Abstract This paper describes validated high-performance liquid chromatographic (LC) and high-performance thin-layer chromatographic (TLC) methods for the simultaneous estimation of olanzapine and fluoxetine in pure powder and tablet formulations. The LC separation was achieved on a Lichrospher 100 RP-180, C18 column (250 mm, 4.0 mm id, 5 m) using 0.05 M potassium dihydrogen phosphate buffer (pH 5.6 adjusted with o-phosphoric acid) acetonitrile (50 + 50, v/v) as the mobile phase at a flow rate of 1 mL/min and ambient temperature. The TLC separation was achieved on aluminum sheets coated with silica gel 60F254 using methanoltoluene (40 + 20, v/v) as the mobile phase. Quantitation was achieved by measuring ultraviolet absorption at 233 nm over the concentration range of 1070 and 40280 g/mL with mean recovery of 99.54 0.89 and 99.73 0.58% for olanzapine and fluoxetine, respectively, by the LC method. Quantitation was achieved by measuring ultraviolet absorption at 233 nm over the concentration range of 100800 and 4003200 ng/spot with mean recovery of 101.53 0.06 and 101.45 0.35% for olanzapine and fluoxetine, respectively, by the TLC method with densitometry. These methods are simple, precise, and sensitive, and they are applicable for simultaneous determination of olanzapine and fluoxetine in tablet formulations.


Author(s):  
Dinh Hai Le ◽  
Thu Nguyen Thi ◽  
Trang Vu Thi ◽  
Thuy Le Thi ◽  
◽  
...  

This study aimed to develop a HPLC method to simultaneously analyze guanosine 5’-monophosphat (GMP) and inosine 5’-monophosphat (IMP) in food products. Sample preparation procedure was simple, fast. A C18 column (250 mm × 4.6 mm, 5 µm) was used as stationary phase, and a mixture of 10 mM potassium dihydrogen phosphate and 5 mM sodium heptanesulfonate was applied as mobile phase, and PDA detector at 250 nm. The method validation followed AOAC criteria. Selectivity, linearity (R2 > 0.999), recovery (IMP: 90.5 % - 102.8 %, GMP: 91.5 % - 103.9 %), repeatability (RSDR of IMP: 3.07 % and GMP: 2.83 %) were acceptable to determination GMP and IMP in food matrix under AOAC guidelines. LOD of GMP and IMP were of 2.32 and 2.77 mg/kg, respectively. This method was used to determination GMP, IMP in food products collected in Hanoi markets.


Author(s):  
Senthil Rajan Dharmalingam ◽  
Srinivasan Ramamurthy ◽  
Sai Siddhardh ◽  
M. D. Basheerudhin

A new selective and sensitive high-performance liquid chromatography method was developed for the quantification of Naproxen in human plasma using diclofenac sodium asinternal standard (IS). Chromatographic separation was achieved on aPhenomenex GEMINI C18 (150 x 4.6 mm, 5 mm) column. The mobile phase consists of a mixture of Acetonitrile: 0.5% Triethylamine buffer (50:50; v/v) and the pH of the mobile phase was adjusted to 3.5 by 85 % orthophosphoric acid. Flow rate of mobile phase was 1 mL/min.Detection was performed at 230nm. The calibration curve was linear over the concentration range from 10 to 120µg/mL. The detection (LOD) and quantification (LOQ) limits were 10 ng/mL and 25 ng/Ml respectively. The method was validated for accuracy, precision, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines.The developed method for the determination of Naproxen from human plasma has been found accurate, precise, selective, and suitable for the bioequivalence and pharmacokinetic studies.


Author(s):  
Sufiyan Ahmad ◽  
Mohammed Rageeb Mohammed Usman

  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.


Author(s):  
V. Tejasvi Reddy ◽  
S. Hari Hara Kumar ◽  
M Akiful Haque ◽  
Vasudha Bakshi

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.


Author(s):  
Choudhary B. ◽  
Goyal A. ◽  
Khokra S. L. ◽  
Kaushik D.

A simple, accurate and reproducible HPLC method have been developed for simultaneous estimation of Diclofenac sodium and rabeprazole from their tablets formulations. A phenomenex C18 (Luna) column of length 250×7.5 mm with particle size of the stationary phase 5 μm and S mobile phase potassium dihydrogen phosphate buffer (pH adjusted to 7.5 with 1 M sodium hydroxide) and acetonitrile in the ratio 60: 40 were used in this study. Retention time was found to be 9.20 min and 6.40 min for Rabeprazole and diclofenac sodium respectively. While that for internal standard as domperidone was 11.87 min at a flow rate of 2ml / min. Linearity was found in the concentration range of 10-50 μg /ml for both the drugs in this method. The results of analysis have been validated statistically and also by recovery studies.


Author(s):  
Sahebrao H. Shembade ◽  
Sagar S. Landage ◽  
Ashapak M. Tamboli ◽  
Ritesh S. Bhate ◽  
Kaustubh V. Gavali ◽  
...  

A rapid and precise high performance liquid chromatography method has been developed for the validation of Salmeterol xinofoate in its pure dosage form. The separation was carried out on Agilent Zorbax Bonus RP- (250mm ×4.6mm 5μ) column with a mobile phase consisting of 0.1% Formic acid: Acetonitrile in the ratio of 64:36 v/v as a mobile phase and flow rate is 1ml/min. The detection was carried out at wavelength 234nm. The column thermostatically controlled at 30℃. The retention time of Salmeterol was found to be 1.96 min. The Salmeterol xinofoate followed linearity in the concentration range of 40-60μg/mL with r2= 0.999. The developed method was validated for sensitivity, accuracy and precision. The sample was scanned from 200- 400nm with PDA detector. The % recovery of sample was found to be. The LOD and LOQ of the Salmeterol xinofoate was found to be 2.67μg/ml and 8.08μg/ml respectively. The suitability of this HPLC method for quantitative estimation of Salmeterol xinofoate was proved by validation by the requirements of ICH guidelines.


Author(s):  
V. Tejasvi Reddy ◽  
S. Hari Hara Kumar ◽  
M Akiful Haque ◽  
Dr. Vasudha Bakshi

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.


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