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 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 STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF DIMETHYL FUMARATE IN BULK AND CAPSULES

2017 ◽  
Vol 9 (5) ◽  
pp. 121 ◽  
Author(s):  
Hemant K. Jain ◽  
Archana A. Gunjal
Keyword(s):  
Dimethyl Fumarate ◽  
Hplc Method ◽  
Assay Method ◽  
Forced Degradation ◽  
Dihydrogen Phosphate ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

Objective: To develop an accurate, simple, precise and specific stability indicating RP-HPLC method for estimation of dimethyl fumarate in bulk and capsules.Methods: An Inertsil ODS (150x4.6 mm, 5µ) column and a mobile phase containing acetonitrile: potassium dihydrogen phosphate buffer pH 6.8 (50:50% v/v) was used for this study. The flow rate was maintained at 1.0 ml/min; column temperature was fixed at 35 °C and UV detection was carried out at 210 nm. The forced degradation studies were performed and method was validated with as per ICH guidelines.Results: The retention time of dimethyl fumarate was found to be 3.3±0.02 min. The value of correlation coefficient between peak area and concentration was found to be 0.9993. The mean percent recovery of dimethyl fumarate in capsules was found in the range of 99.65 to 101.64%. The results of forced degradation studies indicated that the drug was found to be stable in basic, oxidative and thermal conditions while degraded in acidic conditions.Conclusion: It can be conducted from results that the developed HPLC method is simple, accurate, precise and specific. Results of stress testing study revealed that the method is stability indicating. Thus, this method can be used for routine analysis of dimethyl fumarate capsules and check their stability.  

Validated stability indicating assay method of olaparib: LC-ESI-Q-TOF-MS/MS and NMR studies for characterization of its new hydrolytic and oxidative forced degradation products

2018 ◽  
Vol 160 ◽  
pp. 89-98 ◽  
Author(s):  
Mohit Thummar ◽  
Bhoopendra S. Kuswah ◽  
Gananadhamu Samanthula ◽  
Upendra Bulbake ◽  
Jitendra Gour ◽  
...  
Keyword(s):  
Degradation Products ◽  
Assay Method ◽  
Forced Degradation ◽  
Nmr Studies ◽  
Stability Indicating ◽  
Tof Ms

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.

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