scholarly journals Development of a Stability Indicating RP-UPLC Method for Rapid Determination of Metaxalone and its Degradation Products in Solid Oral Dosage Form

2012 ◽  
Vol 80 (2) ◽  
pp. 353-366 ◽  
Author(s):  
Rakshit Kanubhai Trivedi
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Rapid Determination ◽  
Oral Dosage ◽  
Oral Dosage Form ◽  
Stability Indicating ◽  
Solid Oral Dosage Form

Technical Note: Determination of Cholecalciferol (Vitamin D3) in Standard Reference Material 3532 Calcium-Containing Solid Oral Dosage Form

2017 ◽  
Vol 100 (5) ◽  
pp. 1304-1307 ◽  
Author(s):  
Carolyn Q Burdette
Keyword(s):  
Vitamin D3 ◽  
Dosage Form ◽  
Well Being ◽  
Technical Note ◽  
National Institutes Of Health ◽  
Oral Dosage ◽  
Oral Dosage Form ◽  
Solid Oral Dosage Form ◽  
Immune Health

Abstract Vitamin D is an important nutrient for many areas of human health and well-being, including improved bone strength, muscle movement, cognitive function, and immune health. The National Institute of Standards and Technology, in collaboration with the National Institutes of Health Office of Dietary Supplements, has developed SRM 3532 Calcium-Containing Solid Oral Dosage Form to help address the analytical challenges seen by the dietary supplement communities for the determination of vitamin D3 (cholecalciferol) and elements. Described here is the process to assess the homogeneity and stability of the material, as well as the value assignment of the vitamin D3 levels.

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.

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