scholarly journals ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF LANSOPRAZOLE BY RP-HPLC

2018 ◽  
Vol 6 (4) ◽  
pp. 21-29
Author(s):  
Madhavi K Meher ◽  
Charushila Bhangale ◽  
Ramdas Dholas ◽  
Vandana Aher Prashant ◽  
Rohan Pawar
Keyword(s):  
Chromatographic Method ◽  
Method Development ◽  
Limit Of Detection ◽  
Forced Degradation ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Reciprocating Pump ◽  
Liquid Chromatographic

The objective of this work is to develop a rapid, precise, accurate and sensitive revere phase liquid chromatographic method and Forced degradation studies for the estimation of Lansoprazole. The chromatographic method was standardized for Lansoprazole using Shimadzu HPLC model reverse phase analytical Inspire grace C18 column (250 mm x 4.5 mm, 5mm particle size) with PC-3000-M Reciprocating Pump (40 Mpa) and UV-3000-M Detector, at 285nm and flow rate of 0.8 ml/min. The mobile phase consists of 80:20 Methanol: water. The linearity of proposed method was investigated in the range of 10-50 µm/ml (R2 = 0.999) of Lansoprazole. The limit of detection (LOD) was found to be 0.12 mm/ml. The limit of quantification (LOQ) was found to be 0.36 mg/ml. The retention time of Lansoprazole found to be 5.4 min. The method was statistically validated and % RSD was found to be less than 2 indicating high degree of accuracy and precision. Hence proposed method can be successfully applied for the estimation of Lansoprazole in further studies. Keywords: Lansoprazole, RP-HPLC, Chromatogram, validation, estimation.

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 Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

2021 ◽  
pp. 254-271
Author(s):  
Sayyed Nazifa Sabir Ali ◽  
Lajporiya Mobina ◽  
Manjra Mehfuza ◽  
Patel Seema ◽  
Aejaz Ahmed ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Forced Degradation ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation

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 Favipiravir in Bulk and pharmaceutical dosage form followed by Forced Degradation Studies. Study Design: This was employed for UV-visible (200-400 nm and 400-800 nm respectively) and RP-HPLC method development using C 18 inertsil column and optimization of variables for Favipiravir estimation in bulk and formulations. Place and Duration of the Study: The present work was carried out at Ali-allana College of Pharmacy, Akkalkuwa between the duration of November-2020 to February-2021. Methodology: UV-Spectroscopic method was developed for the estimation of Favipiravir in the bulk and pharmaceutical dosage form. The solvent selected for the Favipiravir UV analysis was water, the solution in a range of 2-10µg/ml was scanned in the UV region from 200-400 nm and the λmax value was determined. The RP-HPLC method was developed on inertsil ODS-3V C18 150 mm x 4.6mm x 5μ column using buffer pH 3.5: acetonitrile [90:10] as mobile phase at flow rate 1.0 ml/min and PDA detection at 358 nm. Results: The maximum absorbance was observed at 358 nm. The wavelength 358 nm was selected for further analysis of Favipiravir. The calibration curve was determined using drug concentrations ranging from 2-10 µg/ml. The % recovery for accuracy was 100.50-100.76%. The method was to be precise with a % RSD value 0.51-1.37 and 0.77-1.78 for intraday and Interday respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0723 &0.219 µg/ml respectively by UV method. The RP-HPLC method was shown to be linear in the 50-250 μg/ml concentration range. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 2.186 & 6.626 μg/ml respectively. The method was to be precise with a % RSD value 0.25-1.53 and 0.86-1.68 for intraday and inter-day respectively. Conclusion: Here we conclude that the developed UV and RP-HPLC methods are precise, accurate, sensitive, and reproducible for the quantitative estimation of Favipiravir bulk and its formulation. The developed method can be used by the pharmaceutical industries for the routine analysis of Favipiravir, in particular by UV and RP-HPLC. The main features of the proposed method are economic and eco-friendly with less retention time around 5.0 min.

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CURCUMIN AND PIPERINE BY RP-HPLC

2019 ◽  
Vol 11 (1) ◽  
pp. 216 ◽  
Author(s):  
Ramya Kuber B.
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Reverse Phase ◽  
Limit Of Quantification ◽  
Average Percentage ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: To develop a simple, sensitive, specific, accurate reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of curcumin and piperine.Methods: The separation was done using a column Inertsil–ODS C18 (250 mm × 4.6 mm, 5µ particle size) and mobile phase composed of methanol: water (45:55 v/v), flow rate at 1 ml/min and detection was carried out at 282 nm with photodiode array (PDA) detector.Results: The separation of curcumin and piperine were found to be at the retention time of 2.433 min and 3.095 min, respectively. The method was found to be linear at a concentration range 20-80 µg/ml for curcumin and piperine. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.05µg/ml and 0.17µg/ml for curcumin and 0.18µg/ml and 0.53µg/ml for piperine respectively. The average percentage recoveries of curcumin and piperine were in the range of 98-100.6%.Conclusion: A simple and sensitive reverse phase high performance liquid chromatographic method was developed for the estimation of curcumin and piperine.

scholarly journals Analytical Method Development and Validation for the Estimation of Canagliflozin in Bulk and Formulation by RP- HPLC

2018 ◽  
Vol 10 (03) ◽  
Author(s):  
Darshan Bhatt ◽  
Padmini Thatavarthi ◽  
B. Rajkamal
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple and sensitive reverse phase high performance liquid chromatographic method was developed and successively validated for the estimation of Canagliflozin. In the new method, Canagliflozin separation was carried out by the nonpolar inertsil ODS-3 (250 × 4.6 mm, 5μ) column with a mobile phase composition of Ammonium acetate buffer (pH-4.5) and Acetonitrile in the ratio of 30:70% v/v. Canagliflozin was determined at 252 nm using UV detection and the compound was eluted at the retention time of 4.5 min. As per International Conference on Harmonization (ICH) guidelines, the method was validated and the parameters were precision, accuracy, linearity, limit of detection, limit of quantitation and robustness. The chromatographic method was accurate, linear, specific, precise and robust. The results of method concluded that the proposed RP-HPLC method is useful, convenient and reliable in regular analysis of Canagliflozin in bulk and its formulation

scholarly journals Development and Validation of RP-HPLC Assay Method for Vildagliptin Using Qbd Approach and Its Application to Forced Degradation Studies

2016 ◽  
Vol 8 (03) ◽  
Author(s):  
Meetali M. Chaphekar ◽  
Purnima Hamrapurkar
Keyword(s):  
Method Development ◽  
Accurate Determination ◽  
Interaction Effects ◽  
Hplc Method ◽  
Assay Method ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

The concept of Quality by design (QbD) has recently gained importance in the area of analytical method development and involves understanding of the critical factors and their interaction effects by a desired set of experiments. So, the present work describes the development of Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by QbD approach using Design of Experiments and subsequent validation for analysis of Vildagliptin in bulk drug and its pharmaceutical formulation. An efficient experimental design based on systematic scouting of all three key components of the RP‐HPLC method (Buffer pH, Organic Phase-% acetonitrile, Organic Modifier-Methanol) is presented. The significance and interaction effects of these parameters on the response variables (Retention time and tailing factor) were evaluated through statistical analysis tools like Analysis of Variance (ANOVA) and plots which revealed the final chromatographic conditions of the method. The developed method was validated and Forced degradation studies were also carried out in order to determine the stability-indicating nature of the method. The chromatographic separation was achieved on Jasco CrestPack RP C18 (250 × 4.6 mm, 5μ) column using Buffer (pH 6): Acetonitrile: Methanol (70:10:20 v/v) as mobile phase and detection was done using Photo-Diode Array (PDA) detector at 210 nm. The developed method of Vildagliptin is linear over a range of 5-15μg/ml having correlation coefficient R2 value as 0.999. The %RSD for precision and accuracy of the method was found to be less than 2%. Forced Degradation studies revealed that the method was found to be stability-indicating. The results showed that the proposed method is suitable for the precise and accurate determination of Vildagliptin in bulk and its formulation.

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 Stability indicating thin-layer chromatographic method for estimation of antidiabetic drug Remogliflozin etabonate

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Dimal A. Shah ◽  
Ishita I. Gondalia ◽  
Vandana B. Patel ◽  
Ashok Mahajan ◽  
Usmangani Chhalotiya ◽  
...  
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Tablet Formulation ◽  
Base Hydrolysis ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Remogliflozin Etabonate

Abstract Background A sensitive, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the analysis of Remogliflozin etabonate in tablet formulation. HPTLC plates precoated with silica gel 60 F254 were used as the stationary phase; methanol: ethyl acetate: toluene: NH3 (2:4:4:0.1, v/v/v) was used as mobile phase, and densitometry was used for the quantitative estimation of the drug. The proposed method was validated with respect to linearity, accuracy, precision, and robustness and applied for the estimation of drug in tablet dosage form. Results The Rf value of Remogliflozin etabonate was observed to be 0.61. The densitometric estimation was performed in reflectance mode at 229 nm. The method was found to be linear in the range of 500–8000 ng/band for Remogliflozin etabonate. The possible degradation pathway was estimated by performing forced degradation studies. The degradant peaks were well resolved from the drug peak with acceptable resolution in their Rf value. Conclusion An accurate and precise high-performance thin-layer chromatographic method has been developed for the quantification of Remogliflozin etabonate in tablets. Forced degradation studies were performed, and drug was found to be highly susceptible to acid, base hydrolysis, and oxidative stress degradation and gets converted into active drug Remogliflozin. Both Remogliflozin etabonate and Remogliflozin bands were well resolved. The method was applied for the analysis of drug in tablet formulation, and it can be used for routine quality control analysis, as well as for the analysis of stability samples.

Sign in / Sign up

Export Citation Format

Share Document