Simultaneous Estimation of Torsemide and Spironolactone and forced Degradation Studies in Bulk and Combined Dosage form by RP-HPLC

2018 ◽  
Vol 9 (1) ◽  
Author(s):  
S.RAJA LAKSHMI ◽  
L.KIRAN KUMAR ◽  
V.KRISHNA PRIYANKA ◽  
Y.MANO HAR
Keyword(s):  
Dosage Form ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

scholarly journals RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF LAMIVUDINE AND RALTEGRAVIR IN SOLID DOSAGE FORM

2018 ◽  
Vol 10 (6) ◽  
pp. 242
Author(s):  
Juluri Krishna Dutta Tejaswi ◽  
R. Govinda Rajan
Keyword(s):  
Correlation Coefficient ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

Objective: A stability indicating reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of the combined tablet formulation of lamivudine (LAM) and raltegravir (RAL) in dosage forms and its API.Methods: Chromatographic separation was achieved on inertsil ODS C18 5 µm (4.6 X 150 mm) using a mobile phase (MP) consisting of a mixture of mixed orthophosphoric acid (OPA): acetonitrile (ACN) in the ratio 50:50 v/v which was determined at 242 nm respectively. Results: The assay of LAM and RAL was performed with tablets, and the % assay was found to be 100.12 and 99.89 which shows that the method is useful for routine analysis. The linearity of LAM and RAL was found to be linear with a correlation coefficient of 0.998 and 0.999, which shows that the method is capable of producing good sensitivity. The retention time of LAM and RAL was 1.99 min and 4.34 min respectively; linearity range was found to lie from 15 µg/ml to 75 µg/ml for LAM, 30 µg/ml to 150 µg/ml for RAL with a correlation coefficient of 0.999 respectively. Forced degradation studies were conducted in acidic, basic, thermal, photolytic and peroxide where all the degradation peaks were monitored.Conclusion: The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of LAM and RAL in bulk and tablet dosage form. Thus the validated economical method was applied for forced degradation study of LAM and RAL tablet.

scholarly journals REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE IN SOLID DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 112
Author(s):  
Juluri Krishna Dutta Tejaswi ◽  
Govinda Rajan R
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Forced Degradation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Tenofovir Alafenamide

Objective: A stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of emtricitabine (EMT), rilpivirine (RIL), and tenofovir alafenamide (TAF) in combined dosage forms and its API.Methods: Chromatographic separation was achieved on Waters ACQUITY RP-HPLC with PDA detector having Zodiac C18 Column (250×4.6×5μ) using mobile phase mixture of phosphate buffer: acetonitrile in the ratio of 40:60 v/v at 262 nm.Results: The assay was performed with tablets, and the % assay was found to be 100.104 for EMT, 99.74 for RIL, and 102.41 for TAF which shows that the method is useful for routine analysis. The linearity was found to be linear with a correlation coefficient of 0.999, which shows that the method is capable of producing good sensitivity. The retention time (RT) of EMT, RIL, and TAF using optimum conditions was found to be 2.517, 3.273, and 6.697 min. Forced degradation studies (FDS) were performed on sample using acid, base, thermal, photolytic, and peroxide degradation.Conclusion: Due to its simplicity, rapidness, high precision, and low RT value, this method was successfully applied to the estimation of EMT, RIL, and TAF combined dosage form. The drugs were found to be stable at FDS, and the net degradation was found to be within the limits.

scholarly journals Rp-Hplc Method for Estimation of Metoprolol Succinate and Olmesartan Medoxomil in Pharmaceutical Formulation with forced Degradation Studies

2019 ◽  
Vol 4 (03) ◽  
pp. 34-42
Author(s):  
T. Hemant Kumar ◽  
Samata Samantaray ◽  
D. Gowri Sankar
Keyword(s):  
Olmesartan Medoxomil ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Metoprolol Succinate ◽  
Rp Hplc ◽  
Water Ph ◽  
Forced Degradation Studies ◽  
Degradation Studies

A simple, specific, accurate, and precise RP-HPLC method was developed and validated for the simultaneous estimation of Metoprolol Succinate and Olmesartan Medoxomil in pharmaceutical formulation with forced degradation studies. The method was developed using Enable C 18G column (250 ×4.6 mm, 5 μm) with mobile phase consisting of methanol and water (pH adjusted to 3.5 with orthophosphoric acid in the ratio of 80: 20 % v/v with a flow rate of 1 mL/min. The UV detection was carried out at 240 nm. The retention time for Metoprolol Succinate and Olmesartan Medoxomil were found to be 3.986 and 6.092 min, respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD, and LOQ. Linearity was observed over a concentration range 4-40 μg/mL for Metoprolol Succinate (r2 = 0.9999) and 5-60 μg/ml for Olmesartan Medoxomil (r2 = 0.9999). The % RSD for Intraday and Interday precision was found to be 0.57 and 0.68 for Metoprolol Succinate and 0.52 and 0.41 for Olmesartan Medoxomil. The LOD and LOQ were found to be 0.1143 μg/mL and 0.3565 μg/mL for Metoprolol Succinate and LOD and LOQ were found to be 0.0563 and 0.1782 μg/mL for Olmesartan Medoxomil respectively.

scholarly journals REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE IN SOLID DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 112
Author(s):  
Juluri Krishna Dutta Tejaswi ◽  
Govinda Rajan R
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Forced Degradation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Tenofovir Alafenamide

Objective: A stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of emtricitabine (EMT), rilpivirine (RIL), and tenofovir alafenamide (TAF) in combined dosage forms and its API.Methods: Chromatographic separation was achieved on Waters ACQUITY RP-HPLC with PDA detector having Zodiac C18 Column (250×4.6×5μ) using mobile phase mixture of phosphate buffer: acetonitrile in the ratio of 40:60 v/v at 262 nm.Results: The assay was performed with tablets, and the % assay was found to be 100.104 for EMT, 99.74 for RIL, and 102.41 for TAF which shows that the method is useful for routine analysis. The linearity was found to be linear with a correlation coefficient of 0.999, which shows that the method is capable of producing good sensitivity. The retention time (RT) of EMT, RIL, and TAF using optimum conditions was found to be 2.517, 3.273, and 6.697 min. Forced degradation studies (FDS) were performed on sample using acid, base, thermal, photolytic, and peroxide degradation.Conclusion: Due to its simplicity, rapidness, high precision, and low RT value, this method was successfully applied to the estimation of EMT, RIL, and TAF combined dosage form. The drugs were found to be stable at FDS, and the net degradation was found to be within the limits.

scholarly journals An Eco-friendly RP-HPLC and UV-Method Development and Validation for an Estimation of Tolvaptan in Bulk and Tablet Dosage form Followed by Forced Degradation Studies

2021 ◽  
pp. 271-286
Author(s):  
Patel Seema A. ◽  
Sayyed Nazifa S. ◽  
Lajporiya Mobina I. ◽  
Manjra Mehfuza U. ◽  
Aejaz Ahmed ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Forced Degradation ◽  
Rp Hplc ◽  
Drug Concentrations ◽  
Forced Degradation Studies ◽  
Method Development And Validation ◽  
Degradation Studies ◽  
Development And Validation ◽  
Tablet Dosage

Aims: To develop and validate a new, simple, rapid, precise, and accurate An Eco-friendly RP-HPLC and UV-Method Development and Validation for an estimation of Tolvaptan in Bulk and Tablet dosage form followed by Forced Degradation Studies Place and Duration of the Study: The present work has been carried out at Ali-Allana College of Pharmacy, Akkalkuwa between November-2020 to April-2021. Methodology: The UV-Spectroscopic method was developed for the estimation of tolvaptan in bulk and tablet dosage form. The solvent selected for the tolvaptan UV analysis was 4% aq. SLS solution, the solution of 10µg/ml was scanned in UV region from 200-400 nm and the λmax value was determined. The RP-HPLC method was developed on Sunsil C18 150 mm x 4.6mm x 5μ column using acetonitrile: water [45:55] as mobile phase at flow rate 1.0 ml/min and UV detection at 266 nm. Results: The maximum absorbance was observed at 266 nm. The wavelength 266 nm was selected for further analysis of tolvaptan. The calibration curve was determined using drug concentrations ranging from 20-100 µgm/ml. The system suitability was performed by injecting a standard solution containing 200µg/ml of tolvaptan in six replicates. For two of them, the peak asymmetric were <1.5 and the theoretical plate number was >2000, and the %RSD of tolvaptan was less than 2. Conclusion: From the above results, it was concluded that the developed UV and RP-HPLC methods are precise and accurate and can be applied for the quantitative estimation of tolvaptan from bulk and tablet dosage forms. The method can be used for routine testing of tolvaptan by the pharmaceutical industry. Validation of the developed method was done as per International Conference on Harmonization (ICH) Q2R1 guidelines.

Sign in / Sign up

Export Citation Format

Share Document