scholarly journals Stability-Indicating LC Method for the Determination of Prasugrel Hydrochloride in Pharmaceutical Dosage Form

2012 ◽  
Vol 80 (2) ◽  
pp. 379-391 ◽  
Author(s):  
Vinod K. Ahirrao
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating

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.

Stability Indicating HPTLC Determination of Linezolid as Bulk Drug and in Pharmaceutical Dosage Form

2003 ◽  
Vol 29 (10) ◽  
pp. 1119-1126 ◽  
Author(s):  
Himani Agrawal ◽  
K. R. Mahadik ◽  
A. R. Paradkar ◽  
Neeraj Kaul
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Bulk Drug

scholarly journals STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF GLASDEGIB IN BULK AND PHARMACEUTICAL DOSAGE FORM

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
P. Venkateswara Rao ◽  
P. Meghana ◽  
J. Bhavana ◽  
K. Bhagya Lakshmi ◽  
K. Ramya
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc
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