Determination of pKa values of active pharmaceutical ingredients

2007 ◽  
Vol 26 (11) ◽  
pp. 1043-1061 ◽  
Author(s):  
Sandra Babić ◽  
Alka J.M. Horvat ◽  
Dragana Mutavdžić Pavlović ◽  
Marija Kaštelan-Macan
Author(s):  
Rajan V. Rele ◽  
Sandip P. Patil

A simple, rapid and accurate high performance liquid chromatography method is described for simultaneous determination of emtricitabine and tenofovir disoproxil fumarate from active pharmaceutical ingredients. The separation of drug was achieved on Hypersil BDS C18 (150 x 4.6 mm i.d.) with 5 µ particle size column showed most favorable chromatographic pattern over the other columns. The mobile phase consisted of a mixture of buffer and methanol (85:15 % v/v). The buffer was mixtures of 0.1 % (v/v) ortho-phosphoric acid solution adjusted the pH 3.5 with tri-ethyl amine. The detection was carried out at wavelength 260 nm. The mixture of buffer of pH 3.5 and methanol (85:15% v/v) was used as a diluent. The method was validated for system suitability, linearity, accuracy, precision, robustness, stability of sample solution. The method has been successfully used to analyze emtricitabine and tenofovir disoproxil fumarate from active pharmaceutical ingredients.


Author(s):  
VISHAL CHAUDHARY ◽  
VASUNDHARA SAXENA

Objective: The objective of this review is to put a light on the development of lamotrigine and its active pharmaceutical ingredients formulation with proper demonstration. Method: In the present work, one of the most imperative spectrophotometric method which is RP-HPLC method has been developed for the quantitative estimation of lamotrigine in bulk and pharmaceutical formulations. UV spectrophotometric method which involves the determination of Lamotrigine in bulk and in bulk drug and pharmaceutical formulation has maximum absorption at 307.5nm in methanol. It obeys Beer’s and Lambert’s law in the concentration range of 5-45 µg/ml. A rapid and sensitive RP- HPLC Method with UV detection (270 nm) for routine analysis of Lamotrigine formulation was developed. Chromatography was performed with mobile phase containing a mixture of methanol and Phosphate buffer (65:35v/v) with flow rate 1.0 ml/min. In the range of 20-100 µg/ml, the linearity of lamotrigine shows a correlation co-efficient of 0.9998. The proposed method was validated by determining sensitivity and system suitability parameters.


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