scholarly journals Force Degradation Study of Tenofovir Disoproxil Fumarate by UV-Spectrophotometric Method

2020 ◽  
Vol 8 (2) ◽  
pp. 21-25
Author(s):  
Debaje Priyanka D ◽  
Chavan Harishchandra H
Keyword(s):  
Spectrophotometric Method ◽  
Tenofovir Disoproxil Fumarate ◽  
Hydrolytic Degradation ◽  
Oxidative Degradation ◽  
Alkaline Condition ◽  
Forced Degradation ◽  
Experimental Conditions ◽  
Stress Degradation ◽  
Degradation Studies ◽  
Product Degradation

Tenofovir disoproxil Fumarate (TDF), acyclic phosphonate nucleotide analogue, used as antiretroviral agents in the treatment of HIV-1 infection.  A stability indicating UV -spectrophotometric method is simple, an accurate and economic, precise and reproducible method has been used for the estimation of Tenofovir disoproxil Fumarate in bulk and tablets dosage form in present work. The wavelength selected for the absorption correction method was 260 nm. The linearity range of 2-10μg/ml proved that it obeyed Beer’s Law and the correlation coefficient (r2) was found to be 0.999 at 260 nm. The drug was subjected to acid, alkali, peroxide, UV and Heat degradation. The force degradation studies of Tenofovir disoproxil Fumarate was done on Stress degradation by hydrolysis under alkaline condition by using 0.1N NAOH was found to be 10.6%. Stress degradation by hydrolysis under acidic condition by using 0.1N HCl and product degradation was found to be 10.95%. Oxidative degradation was done by using hydrogen peroxide and product degradation was found to be 12.22%. Neutral hydrolytic degradation was found to be 12.26%. Forced degradation studies of drug reveal good stability under the chosen experimental conditions.  

scholarly journals RP-HPLC assay method development for Paracetamol and Lornoxicam in combination and characterization of oxidative degradation products of Lornoxicam

2013 ◽  
Vol 19 (4) ◽  
pp. 471-484
Author(s):  
Pritam Jain ◽  
Miketa Patel ◽  
Amar Chaudhari ◽  
Sanjay Surana
Keyword(s):  
Method Development ◽  
Degradation Products ◽  
Oxidative Degradation ◽  
Assay Method ◽  
Forced Degradation ◽  
Control Analysis ◽  
Reverse Phase ◽  
Solution Form ◽  
Forced Degradation Studies ◽  
Degradation Studies

A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Paracetamol and Lornoxicam from tablets and to characterize degradation products of Lornoxicam by reverse phase C18 column (Inertsil ODS 3V C-18, 250 x 4.6 mm, 5 ?). The sample was analyzed using Buffer (0.02504 Molar): Methanol in the ratio of 45:55, as a mobile phase at a flow rate of 1.5 mL/min and detection at 290 nm. The retention time for Paracetamol and Lornoxicam was found to be 2.45 and 9.40 min respectively. The method can be used for estimation of combination of these drugs in tablets. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 249.09 - 747.29 ?g/mL (r2=0.9999) for Paracetamol and 4.0125 - 12.0375 ?g/mL (r2=0.9999) for Lornoxicam. Recoveries from tablets were between 98 and 102%. The method was validated with respect to linearity, accuracy, precision, robustness and forced degradation studies which further proved the stability-indicating power. During the forced degradation studies lornoxicam was observed to be labile to alkaline hydrolytic stress and oxidative stress (in the solution form). However, it was stable to the acid hydrolytic, photolytic and thermal stress (in both solid and solution form). The degraded products formed were investigated by electrospray ionization (ESI) time-of-flight mass spectrometry, NMR and IR spectroscopy. A possible degradation pathway was outlined based on the results. The method was found to be sensitive with a detection limit of 0.193 ?g/ml, 2.768 ?g/ml and a quantitation limit of 0.638 ?g/ml, 9.137 ?g/ml for lornoxicam and paracetamol, respectively. Due to these attributes, the proposed method could be used for routine quality control analysis of these drugs in combined dosage forms.

Stability-indicating stress degradation studies of lafutidine using UV spectrophotometric method

2013 ◽  
Vol 4 (1) ◽  
pp. 21-25
Author(s):  
Kiran V. Jadhav ◽  
Dinesh L. Dhamecha ◽  
Geet P. Asnani ◽  
Pranali R. Patil ◽  
Mrityunjaya B. Patil
Keyword(s):  
Spectrophotometric Method ◽  
Stability Indicating ◽  
Stress Degradation ◽  
Degradation Studies

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.

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