scholarly journals New Salting Out Stability-Indicating and Kinetic Thin Layer Chromatographic Method for Determination of Glimepiride and Metformin HCl Binary Mixture

2015 ◽  
Vol 53 (9) ◽  
pp. 1603-1610 ◽  
Author(s):  
Yahya Abduh Salim Mohamed ◽  
Abdel Maaboud Ismail Mohamed ◽  
Fardous Abdel-Fattah Mohamed ◽  
Sameh Abdel-Raouf Ahmed
Keyword(s):  
Binary Mixture ◽  
Thin Layer ◽  
Chromatographic Method ◽  
Salting Out ◽  
Stability Indicating ◽  
Metformin Hcl

scholarly journals Validated Stability Indicating HPTLC Method for the Determination of Dutasteride in Pharmaceutical Dosage Forms

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Dipti B. Patel ◽  
Natubhai J. Patel ◽  
Sejal K. Patel ◽  
Paresh U. Patel
Keyword(s):  
Thin Layer ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Linear Regression Analysis ◽  
Solvent System ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Wet Heat ◽  
Pure Drug

This paper describes simple, sensitive, precise, specific, and stability-indicating high-performance thin-layer chromatographic method for the determination of dutasteride (DUTA) in bulk and tablet formulation. Validation was carried out in compliance with International Conference on Harmonization guidelines. The thin-layer chromatographic method employed aluminium plates precoated with silica gel G60F254 as stationary phase. The solvent system consisted of toluene/methanol/triethylamine (9 : 2 : 1, v/v/v). This solvent system was found to give compact spots for dutasteride with value 0.71 ± 0.01. Densitometric analysis of DUTA was carried out in the absorbance mode at 274 nm. Linear regression analysis showed good linearity () with respect to peak area in the concentration range of 200–3000 ng per spot. The method was validated for precision, accuracy, specificity, and robustness. Pure drug was subjected to acid and alkali hydrolysis, oxidation, photo degradation, dry heat and wet heat treatment. The drug underwent degradation under acidic, basic, oxidative, and wet heat conditions. The degraded products were well separated from the pure drug. Statistical analysis proved that the method is reproducible and selective for estimation of DUTA in bulk and tablets. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability indicating method.

Stability-indicating thin-layer chromatographic method for determination of darunavir in complex darunavir–β-cyclodextrin in the presence of its degradation products

2014 ◽  
Vol 6 (11) ◽  
pp. 3689-3693 ◽  
Author(s):  
Ana Carolina Kogawa ◽  
Jaqueline Nakau Mendonça ◽  
Norberto Peporine Lopes ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Thin Layer ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Stability Indicating

A method was developed to identify degradation products of the complex darunavir–β-cyclodextrin.

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