scholarly journals Development and Validation of RP-HPLC Chromatographic Dissolution Method for the Simultaneous Estimation of Ramipril and Hydrochlorothiazide from Solid Dosage Formulation

2021 ◽  
pp. 203-217
Author(s):  
Prabhakar V. Raut ◽  
Sudhakar L. Padwal ◽  
Madhusudhan T. Bachute ◽  
Satish A. Polshettiwar
Keyword(s):  
Method Development ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Rp Hplc ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

The present study describes the dissolution method development and validation of Ramipril and Hydrochlorothiazide in tablet dosage form by HPLC Method. A simple, rapid, selective, reproducible and isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated as per ICH guidelines. Analysis was performed on a Thermo, Sunniest C8 (150 mm x 4.6 mm, 5 µm) with the mobile phase consisting of mixing 500 mL of buffer solution and 500 mL of acetonitrile at a flow rate of 1.0mL/min. UV detection was performed at 210nm and the Run time for Ramipril and Hydrochlorothiazide were 10 minutes. The calibration curve was linear (correlation coefficient = 1.000) in the selected range for both analytes. The optimized dissolution conditions include the USP Type 1 (Basket) rotation rate of 100 rpm and 750 mL of 0.1 N Hydrochloric acid as dissolution medium, at 37.0 ± 0.5°C. The method was validated for precision, linearity, specificity, accuracy, limit of quantitation and ruggedness. The system suitability parameters, such as theoretical plate, tailing factor and relative standard deviation (RSD) between six standard replicates were well within the limits. The stability result shows that the drug is stable in the prescribed dissolution medium.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CURCUMIN AND CYCLOSPORINE BY RP-HPLC

2018 ◽  
pp. 26-33
Author(s):  
Neha Desai ◽  
Munira Momin ◽  
Upasana Singh ◽  
Tabassum Khan ◽  
Atul Sherje
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Precision Study ◽  
Development And Validation

Objective: The present work was undertaken with an aim to develop and validate a rapid reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of curcumin and cyclosporine in the capsule dosage form. Methods: The RP-HPLC method for the simultaneous estimation of curcumin and cyclosporine was developed using Agilent (Infinity 1260) HPLC system and Eclipse XDB-C18 (4.6 x 150 mm i.d., 5µ) stationary phase. The optimized mobile phase comprised of acetonitrile: water: methanol (50: 10: 40 v/v/v) pumped at a flow rate of 0.5 ml/min. Separation of drugs was achieved in an isocratic mode and elution was monitored using PDA detector at 214 nm. The method was validated as per ICH-Q2R1 guidelines. Results: Retention time of the curcumin and cyclosporine were found to be 3.073 min and 6.373 min with the correlation coefficient (R2) of 0.9993 and 0.998 respectively. The response of curcumin and cyclosporine was found linear in the concentration range of 8-48 μg/ml and 4-24 μg/ml respectively. The percent recovery values were found in the range of 97-103% indicating satisfactory accuracy of the method. The percent relative standard deviation (% RSD) values for the precision study was less than 2 which suggest that the method is precise. Conclusion: The proposed method was found accurate, precise and specific for the determination of curcumin and cyclosporine in bulk as well as in capsule dosage form. Thus, the present method can be used for routine analysis and quality control of curcumin and cyclosporine in bulk and capsule dosage form.

scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Thymoquinone and Curcumin in Dosage form

2021 ◽  
pp. 53-62
Author(s):  
Prajakta Jagtap ◽  
Namrata Mahajan ◽  
Anjali Parte ◽  
Jeeja Pananchery ◽  
Ashish Jain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Development And Validation

Aim: The aim of work is to develop and validate simple, specific, accurate, precise HPLC method for the estimation of Curcumin (CUR) and Thymoquinone (THQ) simultaneously in bulk and its formulation as per ICH guidelines for analytical method development and validation. Study Design: Developing RP-HPLC method using C-18 Inertsil column and optimization of variables for estimation of Thymoquinone and Curcumin in bulk and formulation. Place and Duration of Study: The present work was carried out at Shri D. D. Vispute College of Pharmacy and Research Center, Panvel in year 2021. Methodology: The RP-HPLC method was developed with an isocratic condition of mobile phase comprising acetonitrile and water in a ratio of (82:18) v/v, at a flow rate of 0.9 mL/minute over Inertsil ODS, 250× 4.6 mm, 5 µm column, at 30°C column oven temperature. Photodiode array at 256 nm was used for detection Results: Retention time for curcumin and thymoquinone was found to be 3.5 and 4.3 mins respectively. The method showed excellent linear response in concentration range of 4-18 µg/mland 10-45 µg/mlfor thymoquinone and curcuminrespectively with correlation coefficient (R2) values of0.999 for both. System precision and method precision studies were less than the maximum allowable limit percentage of relative standard deviation ≤ 2.0 i.e., 1.61 % and 1.62 % for curcumin and 0.47 % and 0.42 % for thymoquinone respectively. Mean % Recovery for both the drugs were within acceptance limits. The developed and validated HPLC method is simple, accurate, precise and suitable for analysis as all the results were within acceptance criteria. Conclusion: The developed RP-HPLC method at single wavelength was validated according to ICH guideline with respect to system suitability, specificity, linearity, accuracy, precision and robustness and can be used for routine quality monitoring of drug in pharmaceutical dosage form.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ALISKIREN AND VALSARTAN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (07) ◽  
pp. 5-9
Author(s):  
L Kalyani ◽  
◽  
A. L. Rao
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the simultaneous estimation of aliskiren and valsartan in combined tablet dosage form. The chromatographic separation of the two drugs was achieved on Symmetry C8 column (250 x 4.6 mm, 5 μm). The mobile phase consisted of acetate buffer: acetonitrile (60:40 V/V) and pH was adjusted to 5.8 with glacial acetic acid was delivered at the flow rate of 1.4 mL/min and detection was performed at 220 nm. Separation was completed within 4 minutes. The calibration curves were linear with a correlation coefficient of 0.999 over the concentration range of 7.5 to 75 µg/mL of aliskiren and 8 to 80 µg/mL of valsartan. The relative standard deviation (RSD) was found

scholarly journals Development and Validation of a Novel RP-HPLC Method for Estimation of Losartan Potassium in Dissolution Samples of Immediate and Sustained Release Tablets

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Harshal A. Pawar ◽  
K. G. Lalitha
Keyword(s):  
Sustained Release ◽  
Theoretical Plate ◽  
Stability Result ◽  
Hplc Method ◽  
Losartan Potassium ◽  
Dissolution Medium ◽  
Rp Hplc ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Sustained Release Tablets

A simple, rapid, selective, and reproducible reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Losartan potassium in dissolution samples of Losartan potassium immediate and sustained release tablets. Analysis was performed on an Agilent, Zorbax Eclipse XDB C18 column (150 mm × 4.6 mm, 5 μm) with the mobile phase consisting of orthophosphoric acid (0.1% v/v)—acetonitrile (55 : 45, v/v) at a flow rate of 1.0 mL/min. UV detection was performed at 225 nm and the retention time for Losartan was about 2.6 minutes. The calibration curve was linear (correlation coefficient = 0.999) in the selected range of analyte. The optimized dissolution conditions include the USP apparatus 2 at a paddle rotation rate of 50 rpm and 900 mL of pH 6.8 phosphate buffer as dissolution medium, at 37.0±0.5∘C. The method was validated for precision, linearity, specificity, accuracy, limit of quantitation, and ruggedness. The system suitability parameters, such as theoretical plate, tailing factor and relative standard deviation (RSD) between five standard replicates, were well within the limits. The stability result shows that the drug is stable in the prescribed dissolution medium.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF THYMOL AND EUGENOL BY USING RP-HPLC IN PURE AND IN EMULGEL FORMULATION

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (07) ◽  
pp. 59-65
Author(s):  
Vinita C. Patole ◽  
Shilpa P. Chaudhari ◽  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Relative Standard ◽  
Peak Areas ◽  
80 A 20 ◽  
Development And Validation

An attempt was made to develop a simple, selective, rapid and precise high-performance liquid chromatography (HPLC) method for simultaneous estimation of thymol and eugenol. Analysis was performed on a C18 column with the mobile phase consisting of solvent %A (water) and solvent %B (acetonitrile) with the following gradient: 0–1 min, 80 % A, 20 % B; 1–7 min, 40 % A and 60 % B; 7–12 min, 10 % A and 90 % B; and 12–15min, 80 % A and 20 % B at a flow rate of 0.6 mL/min. The compounds were well separated on a Thermo Scientific Hypersil BDS RP C18 column (4.6 mm × 150 mm, dp = 5 µm) and ultraviolet detection at 280 nm. The retention times of eugenol and thymol were 10.5 min and 11.6 min, respectively. Validation of the proposed method was carried out according to the guidelines of the International Council on Harmonization (ICH). The linearity of the method is good for thymol and eugenol over the concentration range of 1–50 ppm, and the r 2 values were 0.9996 for both thymol and eugenol. The calculated limit of detection (LOD) value was 0.5ppm and the limit of quantification (LOQ) value was 1ppm for both the analytes. The intra and interday relative standard deviation (RSD) of the retention time and peak areas was less than 3 %.The established method was appropriate, and the two markers were well resolved, enabling efficient quantitative analysis of thymol and eugenol.

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