scholarly journals A Novel Validated RP-HPLC-DAD Method for the Simultaneous Estimation of Metformin Hydrochloride and Canagliflozin in Bulk and Pharmaceutical Tablet Dosage form with Forced Degradation Studies

2015 ◽  
Vol 31 (3) ◽  
pp. 1489-1507 ◽  
Author(s):  
Uttam Panigrahy ◽  
A Reddy
Keyword(s):  
Dosage Form ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Tablet ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Tablet Dosage

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 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.

scholarly journals Validation of a Stability-Indicating RP-HPLC Method for the Determination of Entecavir in Tablet Dosage Form

2010 ◽  
Vol 93 (2) ◽  
pp. 523-530 ◽  
Author(s):  
Sérgio Luiz Dalmora ◽  
Maximiliano da Silva Sangoi ◽  
Daniele Rubert Nogueira ◽  
Lucélia Magalhães da Silva
Keyword(s):  
Dosage Form ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Forced Degradation ◽  
Photodiode Array Detection ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Tablet Dosage

Abstract An RP-HPLC method was validated for the determination of entecavir in tablet dosage form. The HPLC method was carried out on a Gemini C18 column (150 4.6 mm id) maintained at 30C. The mobile phase consisted of acetonitrilewater (95 + 5, v/v)/potassium phosphate buffer (0.01 M, pH 4; 9 + 91, v/v) pumped at a flow rate of 1.0 mL/min. Photodiode array detection was at 253 nm. The chromatographic separation was obtained with a retention time of 4.18 min, and the method was linear in the range of 0.5200 g/mL (r2 0.9998). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients and an increase of the cytotoxicity only by the basic condition. The accuracy was 101.19, with bias lower than 1.81. The LOD and LOQ were 0.39 and 0.5 g/mL, respectively. Method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.

scholarly journals A Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Velpatasvir and Sofosbuvir in Bulk and Its Tablet Dosage Form

2019 ◽  
pp. 1-10 ◽  
Author(s):  
D. Chinababu
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Detection Range ◽  
Rp Hplc ◽  
Tablet Dosage

Aim: The objective of the study was simplest, accurate, precise and robust reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Velpatasvir (VEL) and Sofosbuvir (SOF) in the bulk and its tablet dosage form. Study Design: The Quantitative and Qualitative estimation and designed forced degradation study of Velpatasvir & Sofosbuvir by RP-HPLC. Place and Duration of Study: The study was carried at Santhiram College of Pharmacy and time taken 4 months. Method: The method was attained by used Waters( 5µm, C18 250 x 4.6 mm) column with mobile phase consists of  0.5 mM disodium hydrogen phosphate buffer pH adjusted to 6.5, with Orthophosphoric acid and Methanol in the ratio of 78:22 v/v, a flow rate of 1.0 mL/min and ultraviolet detection at 285 nm. Results: The method was validated as per ICH guidelines with different parameters, the mean retention times of VEL and SOF were found to be 2.8 & 4.7 min respectively. The resolution between VEL and SOF was found to be 10.66. The Correlation coefficients for calibration curves within the detection range of 32.5 - 97.5 and 125 - 375 µg/mL were 0.999 for VEL and SOF respectively. The LOD and LOQ for VEL and SOF were found to be 0.0068-0.029 µg/mL and 0.104-0.342 µg/mL respectively. Conclusion: The results were indicated that the developed method was used for the routine analysis of VEL & SOF combined form in bulk and its commercial formulation. To the best of our knowledge, there was no method of RP-HPLC for the determination of VEL alone or in combination with SOF molecule.

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.

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