scholarly journals Method Development and Validation of Metoprolol and Felodipine by using RP-HPLC in Bulk and Pharmaceutical Dosage Form

2020 ◽  
Vol 11 (4) ◽  
pp. 8047-8053
Author(s):  
Potturi Ramadevi ◽  
Kantipudi Rambabu
Keyword(s):  
High Performance ◽  
Method Development ◽  
Pharmaceutical Preparations ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Concentration Limit ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

The main objective of this research is to develop and validate a simple, specific, precise, sensitive, cost effective and rapid Reversed-Phase High-Performance Liquid Chromatographic (RP-HPLC) method for simultaneous quantification of Felodipine and Metoprolol in bulk and pharmaceutical dosage forms. The separation of the analytes were carried out on a X-bridge phenyl column with a moving phase composed of 0.1 % Tri ethyl amine: acetonitrile (30:70 v/v) delivered at a stream of 1.0 ml/min, and separation has been observed by UV detector, at a detection wavelength of 235 nm. This method was proven to be linear over a concentration limit of 10-150 µg/ml for Metoprolol, 2-30 µg/ml for Felodipine with correlation coefficient of 0.999. The retention time of Metoprolol and Felodipine were 2.936, 4.535 minutes respectively. To separate Metoprolol and Felodipine peaks a run time of 8 min. was used. The validation results were in good agreement with acceptable limits. RSD values which are less than 2.0 % indicating the accuracy and precision of this method. Hence it was evident that the proposed method was said to be a suitable one for the regular analysis and quality control of pharmaceutical preparations which contain these active drugs either individually or in combination.

scholarly journals Development and Validation of a RP-HPLC Method for the Quantification of Omeprazole in Pharmaceutical Dosage Form

2013 ◽  
Vol 5 (2) ◽  
pp. 335-342 ◽  
Author(s):  
R. Kayesh ◽  
M. Z. Sultan ◽  
A. Rahman ◽  
M. G. Uddin ◽  
F. Aktar ◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Quantitative Estimation ◽  
Pharmaceutical Preparations ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Form ◽  
Gradient Condition

A rapid and highly sensitive reversed phase high performance liquid chromatographic method has been developed for quantitative estimation of omeprazole in pharmaceutical preparations. The method has been validated according to FDA and USP guidelines with respect to accuracy, precision, specificity and linearity. The method was developed by using a gradient condition of mobile phase comprising 90% aqueous acetonitrile to 100% acetonitrile for 10 minutes at a flow rate of 0.7 mL/min over C-18 (ODS, 250 x 4.6 mm) column at ambient temperature. More than 97% recovery demonstrated the accuracy of the protocol. Intra-day and inter-day precision studies of the new method were less than the maximum allowable limit (RSD% £ 2.0 according to FDA). The method showed linear response with correlation coefficient (r2) value of 0.998.  Therefore, it was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for the assay of omeprazole formulations.Keywords: HPLC; Method development; Gradient condition; Validation; Omeprazole.© 2013 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.doi: http://dx.doi.org/10.3329/jsr.v5i2.12779        J. Sci. Res. 5 (2), 335-342  (2013)

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF MELATONIN IN TABLET BY USING RP-HPLC

2021 ◽  
Vol 11 (6) ◽  
pp. 54-61
Author(s):  
Khanderao Rajaram Jadhav
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Good Precision ◽  
Good Resolution ◽  
Uv Detector ◽  
Rp Hplc ◽  
Liquid Chromatographic

In the present work new, Simple Reversed-Phase High Performance Liquid Chromatographic method was developed and validated for the estimation of Melatonin in tablets. A sharp peak was obtained 7.125 min using Methanol: Phosphate buffer (PH 3.0) in the ratio of 40:60 as mobile phase at a flow rate of 1.0 ml/min, on HPLC Waters 515 system containing UV detector with Empower software. The separation was achieved on the C18 analytical column (250 mm × 4.6 mm, 5.0 μm). The detection was carried out at 223 nm. The method gave good resolution and suitable retention time. The results of the analysis in this method were validated in terms of specificity, accuracy, precision, linearity, and range. The method was found to be reliable, reproducible, rapid, and economic. The RP-HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for the estimation of Melatonin in tablets.

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FIMASARTAN BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
pp. 138-146
Author(s):  
SRUTHI A ◽  
UTTAM PRASAD PANIGRAHY
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Internal Diameter ◽  
Uv Detector ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

Objective: A rapid, sensitive and specific reverse phase High performance liquid Chromatography (RP-HPLC) method was developed for the estimation of Fimasartan in bulk and pharmaceutical dosage form. Method: The RP-HPLC analysis was performed isocratically on a Primacel C18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size) using mobile phase of composition Acetonitrile and 0.1% orthophosphoric Acid in 80:20, v/v proportions with a flow rate of 0.8 ml/min. Results: The analyte was monitered with UV-detector at 265 nm. In the developed method Fimasartan elutes at a typical retention time of 2.4 min. The proposed method is having linearity in the concentration ranging from 5-30 μg/ml of Fimasartan. Conclusion: : The method was statistically validated and had been applied to analysis of the drug in bulk and pharmaceutical dosage form.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HYDROCHLORIDE USING RAPID HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC TECHNIQUE

2018 ◽  
Vol 11 (11) ◽  
pp. 118
Author(s):  
Zubaidur Rahman ◽  
Vijey Aanandhi M ◽  
Sumithra M
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Sensitivity ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Chromatographic Technique ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of atomoxetine HCl (ATH) in bulk and formulations.Methods: The chromatographic development was carried out on RP-HPLC. The column used as Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size), with mobile phase consisting of methanol: water 80:20 V/V. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm.Results: The retention time was found to be 5.350 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 2–10 μg/mL with a regression coefficient of 0.9999. The method has proved high sensitivity and specificity.Conclusion: The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate which is useful for the routine determination of ATH in bulk drug and in its pharmaceutical dosage form.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF LOPINAVIR IN TABLET DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2018 ◽  
Vol 11 ◽  
Author(s):  
Sunkara Namratha ◽  
Vijayalakshmi A
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: Reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the assessment of lopinavir in the dosage form of tablet.Methods: Chromatogram was run through using Kromosil C18 4.5×150 mm using a mobile phase methanol: water of ratio 65:35% v/v with a rate of flow of 0.8 ml/min, measured by UV spectrometric detection at 265 nm. The method developed was validated in terms of precision, accuracy, linearity, and robustness parameters.Results: Retention time of lopinavir established at 2.482 min and percentage R.S.D of lopinavir found to be 1.0% and 0.5%, respectively. The method shows that good linearity range of 30–150 μg correlation coefficient of lopinavir was 0.997. The limit of detection was 2.97 and limit of quantification was 9.92, respectively. The percent purity of lopinavir was 99.87%.Conclusion: The suggested method (Rp-HPLC) for concurrent assay lopinavir was validated, which is appropriate method for the analysis oflopinavir quantitatively in tablet dosage forms and bulk.

scholarly journals HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN AND SITAGLIPTIN IN PHARMACEUTICAL DOSAGE FORMS AND ITS APPLICATIONS TO DISSOLUTION STUDY

2019 ◽  
Vol 3 (7) ◽  
Author(s):  
Hemraj Sharma ◽  
Boya Madhuri ◽  
Yiragamreddy Padmanabha Reddy ◽  
Kondareddy Vinod Kumar ◽  
Nanda Kishor Bhatta ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Dissolution Study ◽  
Rp Hplc

A novel approach was used to develop and validate a rapid, specific, accurate and precise Reverse phase High performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of Metformin and Sitagliptin in pharmaceutical dosage forms and its applications to dissolution study. The chromatographic separation was carried out on a C8 (250mm X 4.6 mm i.d., 5μm) column with a mobile phase of 40 Acetonitrile: 60 Phosphate Buffer (pH 6.8), using UV detector at 257 nm at 1ml min-1 flow rate. The retention time for Metformin was 2.11 minutes and 5.30 minutes for Sitagliptin. The Linearity for Metformin was found to be 10-80 µg ml-1 with R2 value of 0.9998 and for Sitagliptin 1-8 µg ml-1 with R2 value of 0.9976. Dissolution study of both for Metformin and Sitagliptin was carried, Percentage of drug release was established which was found to be 96.23% and 102.64% respectively, in the period of 50 minutes. Keywords: RP-HPLC, Metformin, Sitagliptin, Dissolution study

scholarly journals Method Development and Validation for Simultaneous Determination of Ezetimibe and Simvastatin In Combined Pharmaceutical Dosage Form By RP-HPLC Method

2013 ◽  
Vol 2 (2) ◽  
pp. 60-69 ◽  
Author(s):  
G Krishnaveni ◽  
PVV Sathyannarayana
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Internal Diameter ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms

A simple, rapid reverse phase high-performance liquid chromatographic method was developed and validated for the simultaneous estimation of Ezetimibe and Simvastatin in bulk and pharmaceutical dosage forms. Chromatography was carried out by using Chromosil C-18,column having 250 x 4.6mm internal diameter with a mixture of Methanol:Acetonitrile:0.1%Orthophosphoric Aid in the ratio of 75:20:05 (v/v/v) as mobile phase. Determination of the different analytical parameters such as linearity, precision, accuracy, and specificity, limit of detection (LOD) and limit of quantification (LOQ) was done. The calibration curve was found to be linear for each analyte in the desired concentration range. The average recovery was found to be 99.88 and 100.12 for Ezetimibe and Simvastatin respectively. The proposed method is highly sensitive, precise and accurate, which was evident from the LOD value of 1.2ppm and 0.25ppm for Ezetimibe and Simvastatin respectively and hence the present method can be applied successfully for the quantification of active pharmaceutical ingredient (API) content in the combined formulations of Ezetimibe and Simvastatin. DOI: http://dx.doi.org/10.3329/ijpls.v2i2.15450 International Journal of Pharmaceutical and Life Sciences Vol.2(2) 2013: 60-69

scholarly journals Development and Validation of a Simple RP-HPLC Method for Determination of Naproxen in Pharmaceutical Dosage Forms

2015 ◽  
Vol 16 (2) ◽  
pp. 137-141 ◽  
Author(s):  
Saleha Tanjin ◽  
Farhana Islam ◽  
Md Zakir Sultan ◽  
Asma Rahman ◽  
Sharmin Reza Chowdhury ◽  
...  
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Uv Detector ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

A simple, sensitive and precise reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of naproxen in pharmaceutical dosage forms. The method was developed using the mobile phase comprising of dibasic sodium phosphate buffer (Na2HPO4) at pH 7.80 (adjusted by sodium hydroxide) and acetonitrile in the ratio of 70:30 (v/v) over C-18 column (250 x 4.6 mm, 5?m, Phenomenex Inc.) at ambient temperature. The flow rate was at 0.7 ml/min and the column washing was monitored by UV detector at 225 nm. The retention time of naproxen was 4.8 ± 0.1 min. The recovery was found to be >97% which is demonstrative of accuracy of the protocol. Inter-day and intra-day precision of the newly developed method were less than the maximum allowable limit (RSD% ? 2.0) according to ICH, USP and FDA guidelines. The method showed linear response with correlation coefficient (r2) value of 0.9991. Therefore, the method was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for routine analysis of naproxen in pharmaceutical formulations. DOI: http://dx.doi.org/10.3329/bpj.v16i2.22295 Bangladesh Pharmaceutical Journal 16(2): 137-141, 2013

scholarly journals RP-HPLC Method development, Validation and Forced Degradation for Simultaneous estimation of Benserazide HCl and Levodopa in a Marketed Formulation

2020 ◽  
Vol 13 (3) ◽  
pp. 206-216
Author(s):  
Madhusudan Bhoir ◽  
Nutan Rao
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Uv Detector ◽  
Column Temperature ◽  
Rp Hplc ◽  
Liquid Chromatographic

The objective of the study was to develop and validate a novel, stability indicating, simple, rapid, accurate, precise and isocratic reverse-phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of benserazide HCl and levodopa in a marketed formulation. Chromatographic separation was achieved by using C18 Cosmosil 4.6 × 250 mm column with a mixture of phosphate buffer pH 2 and acetonitrile in proportion of 95:5 as mobile phase at a flow rate of 1.0 ml/min and column temperature 25°C. The detection was carried out at 210 nm using UV detector. The retention time for benserazide and levodopa was found to be 3.1 minutes and 6.6 minutes respectively and recoveries from tablet were between 98 and 102 %.

scholarly journals Development and Validation of a RP-HPLC Method for Determination of Nimodipine in Sustained Release Tablets

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Xiaojun Shang ◽  
Suying Ma ◽  
Zheshen Li
Keyword(s):  
Sustained Release ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detector ◽  
Rp Hplc ◽  
Sustained Release Tablets ◽  
Liquid Chromatographic

A rapid, sensitive, and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method with UV detector for the determination of nimodipine in sustained release tablets was developed. The method involved using a SinoChoom ODS-BP C18reversed phase column (5 μm, 4.6 mm × 200 mm) and mobile phase consisting of methanol-acetonitrile-water (35 : 38 : 27, v/v). The flow rate is 1.0 mL/min, the UV detector was operated at 237 nm, and the column was maintained at 25°C. The method was validated according to official compendia guidelines. The calibration curve of nimodipine for RP-HPLC method was linear over the range of 10–100 μg/mL. The retention time was found at 7.50 min for nimodipine. The variation for interday and intraday assay was found to be less than 0.72%. The proposed RP-HPLC was proved to be suitable for the determination of nimodipine in sustained release tablets.

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