scholarly journals Development and validation of stability indicating assay method for estimation of lumefantrine in bulk and tablet dosage form

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 1921-1927
Author(s):  
Vijay H Ikale ◽  
Hemant K. Jain ◽  
Ashish B. Budhrani ◽  
Manoj S. Patil ◽  
Tikesh Agrawal ◽  
...  
Keyword(s):  
Chromatographic Analysis ◽  
Mobile Phase ◽  
Assay Method ◽  
Oxidation Condition ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Degradation Studies ◽  
Development And Validation ◽  
Neutral Conditions ◽  
Tablet Dosage

Simple, precise, accurate, sensitive, economical, and rapid stability indicating method was developed for the estimation of Lumefantrine in bulk and tablets. Chromatographic analysis was performed on A Hibar C18 (4.6×250 mm, 5μm) column and mobile phase made up of acetonitrile: methanol (50:50 v/v); used for this study. The flow rate of the mobile phase was to 1.2 ml/min; the temperature of the column was adjusted to 40°C and UV analysis was carried out at 234 nm. The degradation studies were performed and the analytical method was validated as per ICH Q2R1 guideline. The Retention time of Lumefantrine was found to be 8.8 min. The developed method was found to be linear in the concentration range of 10-60 μg/ml. The value of the correlation coefficient between peak area and concentration was found to be 0.995. The value of % RSD was found to be within prescribed limits for precision studies which indicate reproducibility of the method. The values of LOD and LOQ were obtained at 14.54 and 44.07 μg/ml, respectively. The results of degradation studies indicate that the drug was found to be stable in acidic, basic, neutral, photolytic, and neutral conditions while degraded in oxidation condition. 

scholarly journals Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

2021 ◽  
Vol 16 (1) ◽  
pp. 133-149
Author(s):  
Jaya P. Ambhore ◽  
Vaibhav S. Adhao ◽  
Rameshwar S. Cheke ◽  
Rameshwar S. Cheke ◽  
Ritesh R. Popat ◽  
...  
Keyword(s):  
Vital Role ◽  
Antiviral Drugs ◽  
Assay Method ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Stress Studies ◽  
Stability Indicating Method ◽  
Degradation Studies ◽  
Development And Validation

Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summarizes the current regulatory requirements guidelines for the laboratory performance of forced degradation and its application for the development of stability indicating method. There are number of strategies have been implemented for the quantitative assessment of antiviral drugs. This study will provide detailed literature on stability- indicating HPLC/ RP-HPLC approaches for the development and validation of various antiviral drugs.

scholarly journals Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

2017 ◽  
Vol 5 (03) ◽  
pp. 01-06 ◽  
Author(s):  
Gorja Ashok ◽  
Sumantha Mondal
Keyword(s):  
Ultra Performance Liquid Chromatography ◽  
Dosage Forms ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Neutral Conditions ◽  
Tablet Dosage

A Stability Indicating Ultra-Performance Liquid Chromatography method was developed and validated for quantification of Axitinib in tablets. The chromatographic separation was done in an isocratic mode using the STD RP-18 Endcapped (50mm × 4.6mm, 2μ particle size) column. The mobile phase 0.1% OPA and acetonitrile 55:45 (%v/v) at the flow rate of 0.2mL/min and at ambient temperature was used. The wavelength used for detection was 249nm. The retention time for Axitinib was found to 1.03min. Axitinib was linear in the concentration range of 12.5μg/mL to 75μg/mL respectively. The developed method was validated and found to be accurate, specific and robust. The drug was subjected to the stressed conditions like acidic, basic, oxidative, photolytic, thermal and neutral conditions. The degradation results are found satisfactory. This method can be applied for the estimation of Axitinib in pharmaceutical dosage forms.

scholarly journals DEVELOPMENT OF FORCED DEGRADATION STUDIES OF FAVIPIRAVIR BY RP-HPLC

2021 ◽  
Vol 10 (6) ◽  
pp. 3823-3826
Author(s):  
, Shyamala
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Ultra Violet ◽  
Active Pharmaceutical Ingredient ◽  
Spectral Studies ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Forced Degradation Studies ◽  
Degradation Studies

Forced degradation studies and stability indicating method were developed for the estimation of Favipiravir by reverse phase High performance liquid chromatography in active Pharmaceutical ingredient and its tablet dosage form. The method was achieved by using C18 column (250 X 4.6mm X 4µm) with mobile phase mixture ortho phosphoric acid and acetonitrile in the ratio 60:40. The mobile phase was allowed to pump with the flow rate 1ml/min by maintaining detection wavelength at 324nm using ultra-violet detector. Favipiravir drug was subjected to various stress conditions according to International Conference of Harmonization Q1A(R2) guidelines to establish stability indicating method. Favipiravir drug was found to be sensitive at peroxide degradation. The impurity peak was characterized by mass spectral studies. The method was validated for analytical standards such as linearity, accuracy, Precision, sensitivity and robustness. A rapid and sensitive method was developed for the estimation of favipiravir which indicates its stability indicating behavior.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD RP-HPLC METHOD OF ACOTIAMIDE

2018 ◽  
Vol 10 (9) ◽  
pp. 1 ◽  
Author(s):  
Charu P. Pandya ◽  
Sadhana J. Rajput
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Acid And Base ◽  
Stress Degradation ◽  
Development And Validation ◽  
Tablet Dosage

Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of acotiamide in presence of its degradation products.Methods: An isocratic RP-HPLC method has been developed using C-8 Thermo Hypersil BDS Column (250 x 4.6 mm i.d., 5µparticle size) with the mobile phase composition of acetonitrile: 0.1 % triethylamine in 0.2% formic acid (30: 70) at column oven temperature of 40 °C. The flow rate was 1.0 ml min-1 and effluent was detected at 282 nm. The method was validated in terms of linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification) and robustness as per ICH guidelines.Results: The method was found to be linear in the range of 10-60µg/ml. Limit of detection and limit of quantification was found to 0.36µg/ml and 1.10 µg/ml.% Recovery was found to be in the range of 99.45%-99.75%and precision less than 2%. The developed method was successfully applied for estimation of Acotiamide in marketed tablet formulation and percentage assay was found to be 100.45%. Acotiamide was subjected to stress degradation under acid, base, neutral hydrolysis, oxidation, dry heat, photolysis conditions. Significant degradation was observed in acid and base degradation.Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the estimation of Acotiamide in bulk and tablet dosage form.

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UPLC METHOD FOR THE QUANTIFICATION OF BALOXAVIR MARBOXIL IN TABLET FORMULATION

2020 ◽  
pp. 94-99
Author(s):  
T. VENKATA RAVEENDRANATH ◽  
R. T. SARAVANAKUMAR ◽  
C. H. K. V. L. S. N. ANJANA
Keyword(s):  
Retention Time ◽  
Orthophosphoric Acid ◽  
Regression Equation ◽  
Mobile Phase Composition ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Chromatographic Elution ◽  
Quality Control Test

Objective: Aim of the present work is to develop a simple, accurate and precise stability-indicating method for the quantification of baloxavir marboxil (BLMX) in tablet dosage form by UPLC. Methods: Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8 mm) reverse phase column and the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 was processed through a column at a flow rate of 0.3 ml/min. Column oven temperature was maintained at 30 °C and the detection wavelength was processed at 240 nm. Results: Retention time of BLMX was found to be 0.87 min. Repeatability of the method was determined in the form of %RSD and the value was 0.2. The percentage mean recovery of the method was found to be 99.47%. LOD, LOQ values obtained from the regression equation of BLMX were 0.69 and 2.10 mg/ml, respectively. Regression equation and correlation coefficient values of BLMX were y = 16994x+7179.2 and 0.9996. Drug was subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 5.96% and 9.55%. Conclusion: Retention time and total run time of the drug was decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of BLMX.

scholarly journals Development and Validation of Stability Indicating HPTLC Method for Determination of Diacerein and Aceclofenac as Bulk Drug and in Tablet Dosage Form

2012 ◽  
Vol 9 (4) ◽  
pp. 2023-2028 ◽  
Author(s):  
S. P. Gandhi ◽  
M. G. Dewani ◽  
T. C. Borole ◽  
M. C. Damle
Keyword(s):  
Assay Method ◽  
Stability Indicating ◽  
Dry Heat ◽  
Wet Heat ◽  
Anti Inflammatory ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

Diacerein is a drug for osteoarthritis and is di-acetylated derivative of rein. Aceclofenac is used as an effective non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. The present study describes degradation of diacerein and aceclofenac under ICH prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat, and photolysis) and establishment of a stability-indicating HPTLC assay method. Different degradation peaks were observed for diacerein when it was exposed to alkaline, and acid catalysed hydrolysis. For aceclofenac, decrease in peak area was observed with single peak of degradation product after oxidation. For HPTLC, RP-18 F254spre-coated plates, and mobile phase consisting of methanol: water 7: 3 v/v was used to achieve separation. Quantitation was done at 268 nm. The method was validated as per ICH Q2 R1 guidelines and results were in limit. The method was found to be simple, specific, precise, and stability indicating.

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