研究目的
To develop and validate a simultaneous UV-spectrophotometric method for the determination of ranitidine hydrochloride and itopride hydrochloride in a binary mixture.
研究成果
The developed UV-spectrophotometric method is rapid, simple, accurate, and precise for simultaneous determination of ranitidine hydrochloride and itopride hydrochloride in binary mixtures within the concentration range of 5-20 μg/ml. It is validated statistically, but further specificity confirmation with HPLC is recommended.
研究不足
The method lacks specificity as it cannot distinguish between the two drugs without additional techniques like HPLC. Ruggedness was not evaluated due to equipment limitations. The linearity range is limited to 2-20 μg/ml, and precision for itopride (%RSD = 3.51) exceeds the acceptance criteria of 2.0.
1:Experimental Design and Method Selection:
A UV spectrophotometric method using simultaneous equations was developed. The method involved selecting two analytical wavelengths (315 nm and 258 nm) where each drug has maximum absorbance, and using absorptivity values to solve simultaneous equations for concentration determination.
2:Sample Selection and Data Sources:
Pure ranitidine hydrochloride and itopride hydrochloride were used as samples, obtained as gifts from Strides Acrolab and Themis Pharma Pvt Ltd, respectively. Standard solutions were prepared in double distilled water.
3:List of Experimental Equipment and Materials:
Double beam UV-Vis spectrophotometer (Shimadzu Pharmaspec 1700), volumetric flasks, pipettes, beakers, analytical balance (Dwijo, 200 G), cuvettes (1 cm path length), distilled water from Barnstead distillation apparatus.
4:Experimental Procedures and Operational Workflow:
Stock solutions of 1000 μg/ml were prepared and diluted to working standards. Absorbance was measured at 315 nm and 258 nm for pure drugs and mixtures. Simultaneous equations were constructed and solved using Cramer's rule with MS Excel and VB applications.
5:Data Analysis Methods:
Linear regression was used to determine absorptivity values. Statistical validation included specificity, linearity, precision, accuracy, LOD, LOQ, and range calculations.
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UV-Vis Spectrophotometer
Pharmaspec 1700
Shimadzu
Measuring absorbance of solutions at specific wavelengths for quantitative analysis.
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Analytical Balance
Dwijo, 200 G
Dwijo
Weighing samples and reagents accurately.
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Distillation Apparatus
Barnstead type steel
Barnstead
Producing double distilled water for use as solvent.
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Volumetric Flask
100 ml
Borisil
Preparing and diluting standard solutions.
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Graduated Pipette
10 ml
Borisil
Measuring and transferring liquid volumes accurately.
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Beaker
100 ml
Borisil
Holding and mixing solutions.
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Beaker
50 ml
Borisil
Holding and mixing solutions.
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Cuvette
1 cm
Holding samples for absorbance measurement in the spectrophotometer.
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