Application of quinone-based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline- induced degradation products by LC-MS/TOF

Luminescence ◽  
2017 ◽  
Vol 33 (1) ◽  
pp. 225-231 ◽  
Author(s):  
Fawzia Ibrahim ◽  
Asmaa Kamal El-Deen ◽  
Kuniyoshi Shimizu
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Native Fluorescence ◽  
Form Identification ◽  
Spectrofluorimetric Determination

Development and Validation of Two Robust Stability-Indicating Chromatographic Methods for Determination of Metolazone in Drug Substance and Pharmaceutical Dosage Form in the Presence of Its Degradation Products and Characterization of Main Degradation Products Based on LC-MS

2019 ◽  
Vol 58 (3) ◽  
pp. 251-261
Author(s):  
Hala E Zaazaa ◽  
Rasha Abdel-Ghany ◽  
M Abdelkawy ◽  
Mahmoud Sayed
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Hplc Method ◽  
Drug Substance ◽  
Design Parameters ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Chromatographic Methods ◽  
Hptlc Method

Abstract Two robust and selective stability-indicating chromatographic methods were developed and validated for the determination of metolazone in drug substance and pharmaceutical dosage form in the presence of its degradation products. The HPLC method employed a Kromasil C18 (250 × 4.6,5 μm) column and a mobile phase of acetonitrile: 0.2% orthophosphoric acid (32:68 v/v) at a flow rate 2 mL/min and detection at 238 nm. The separation was performed in HPLC isocratic mode. The robustness of the suggested method was assessed using the Plackett–Burman design, parameters affecting system suitability were established and non-significant intervals for the significant parameters were considered. The HPTLC method employed Nano-SIL-20 UV254 HPTLC plates as adsorbent, ethyl acetate: toluene: acetic acid solution (4:4:0.5, v/v/v), as a developing solvent system and densitometric detection at 238 nm. Metolazone was exposed to different stress conditions, including acid and alkaline hydrolysis and oxidative and photolytic degradation. The main degradation products obtained have been characterized and interpreted based on LC-MS. The linearity of the suggested methods was proved in the concentration range of 20–75 μg/mL for the HPLC method and 100–900 ng/spot for the HPTLC method. The suggested methods were validated according to international conference on harmonization guidelines. These methods were successfully dedicated for the estimation of metolazone in drug substance and pharmaceutical dosage form in the presence of its degradation products. The results of the suggested methods were evaluated and compared statistically with results obtained by an official method without finding any significant difference.

scholarly journals Development and Validation of RP-UPLC Method for the Determination of Iloperidone, Its Related Compounds and Degradation Products in Bulk and Dosage Form

2014 ◽  
Vol 05 (14) ◽  
pp. 969-981 ◽  
Author(s):  
Shashikant B. Landge ◽  
Sanjay A. Jadhav ◽  
Shrihari P. Vishwambar ◽  
Pavankumar V. Solanki ◽  
Saroj R. Bembalkar ◽  
...  
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Development And Validation ◽  
Related Compounds

New Rapid Stability indicating RP-UPLC Method for the Determination of Olaparib, its Related Substances and Degradation Products in Bulk drug and Dosage Form

2019 ◽  
Vol 14 ◽  
pp. 492-503
Author(s):  
DasameswaraRao Kavitapu ◽  
Arthanareeswari Maruthapillai ◽  
S. Devikala ◽  
J. Arockia Selvi ◽  
M. Tamilselvi ◽  
...  
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Stability Indicating ◽  
Related Substances ◽  
Bulk Drug

scholarly journals Stability Indicating RP-HPLC Method for the Simultaneous Determination of Atorvastatin Calcium, Metformin Hydrochloride, and Glimepiride in Bulk and Combined Tablet Dosage Form

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Devi Ramesh ◽  
Mohammad Habibuddin
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Atorvastatin Calcium ◽  
Rp Hplc ◽  
Specificity And Sensitivity ◽  
Validation Parameters ◽  
Tablet Dosage

A simple, rapid, and precise RP-HPLC method for simultaneous analysis of atorvastatin calcium, metformin hydrochloride, and glimepiride in bulk and its pharmaceutical formulations has been developed and validated. These drugs were separated by using Grace Smart Altima C-8 column (250 × 4.6 mm, 5-μm) with a mobile phase consisting of acetonitrile : phosphate buffer (60 : 40 (v/v), pH 3.0) at a flow rate of 1 mL/min, injection volume 25 µL, and detection at 235 nm. Metformin, atorvastatin, and glimepiride were eluted with retention times of 2.57 min, 7.06 min, and 9.39 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH (Q2B) guidelines. The results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 10 to 150 µg/mL, 20 to 200 µg/mL, and 10 to 150 µg/mL for atorvastatin, metformin, and glimepiride, respectively. The accuracy and precision were found to be between 98.2%–105% and ≤2% for three drugs. Developed method was successfully applied for the determination of the drugs in tablet dosage form and recovery was found to be >98% for three drugs. The degradation products produced as a result of stress studies did not interfere with drug peaks.

scholarly journals ESTUDO DE ESTABILIDADE DO FOSFATO DISSÓDICO DE PREDNISOLONA EM CONDIÇÕES DE ESTRESSE OXIDATIVO E TÉRMICO, EM FORMULAÇÃO ORAL

2018 ◽  
Vol 35 (4) ◽  
pp. 09
Author(s):  
Cleber Antonio Lindino ◽  
Marcia Lina Mitsui ◽  
Rodolfo Ortiguara ◽  
Daiane Felin ◽  
Mauricio Ferreira Da Rosa ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Degradation Products ◽  
Degradation Process ◽  
Oral Solution ◽  
Form Solution ◽  
Oral Dosage ◽  
First Order ◽  
First Order Kinetics

This work was to investigate the process of degradation of the drug Prednisolone Sodium Phosphate (FSP) in oral solution dosage form through the degradation experiments, evaluating the parameters in accordance with Resolution 899/2003 ANVISA and the degradation process of the drug. The method by high performance liquid chromatography (HPLC) developed for the determination of the drug was validated to demonstrate its applicability as an indicator of stability, ensuring reliability. After the method be validated to study the degradation of the drug, it was shown that drastic conditions of oxidative stress (H O 30%) and 2 2 temperature 60°C, the degradation of the drug is dependent on its concentration (first order kinetics). The results were  satisfactory, showing that this method is suitable to investigate the formation of degradation products in oral dosage form solution

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