Abstract
In this study, a derivative spectrophotometric method and one HPLC method were developed and validated for analysis of anti-diabetic drugs, repaglinide (RPG) and metformine hydrochloride (MTF) in tablets. The spectrophotometric methods were based on zero-crossing first-derivative and fourth-derivative spectrophotometric method for simultaneous analysis of RPG (308 nm) and MTF (267 nm), respectively. Linear relationship between the absorbance at λmax and the drug concentration was found to be in the ranges of 5.0 - 50.0 μg·mL-1 for both RPG and MTF. The quantification limits for RPG and MTF were found to be 0.568 and 1.156 μg·mL-1, respectively. The detection limits were 0.170 and 0.347 μg·mL-1 for RPG and MTF, respectively. The second method is a rapid stability-indicating isocratic HPLC method developed for the determination of RPG and MTF. A linear response was observed within the concentration range of 5.0 - 50.0 μg·mL-1 for both RPG and MTF. The quantification limits for RPG and MTF were found to be 1.821 and 1.653 μg·mL-1, respectively. The detection limits were 0.601 and 0.545 μg·mL-1 for RPG and MTF, respectively. The proposed methods were successfully applied to the tablet analysis with good accuracy and precision.
Highlights
HPLC Method Two diluted standards were prepared from the stock solutions of RPG and metformine hydrochloride (MTF), as follows: Series A: Different aliquots of RPG solution (0.125 - 1.25 mL) were transferred to 5 mL volumetric flask to provide final concentration range 5.0 - 50.0 μg·mL−1 and the volume was diluted to volume with mobile phase (acetonitrile-ophosphoric acid (40:60), v/v)
For the simultaneous analysis of these drugs, a zero crossing first-derivative and fourth-derivative spectrophotometric method was developed in fixed dose combination tablet preparations
Derivative spectrophotometry based on a mathematical transformation of the zero-order curve into the derivative spectra can overcome that problem [14] [15]
Summary
Metformin and phenformin are the most commonly used drugs in biguanide class that have been established in the therapy of non-insulin-dependent diabetes mellitus for decades. After the introduction of sulfonylureas, biguanides were nearly eliminated from the market, largely because of the risk of severe lactic acidosis [1]. Metformin hydrochloride (1,1-dimethylbiguanide hydrochloride) (Figure 1(a)) doesn’t cause hypoglycaemica or lactic acidosis like other hypoglycaemic agents. It is the most commonly used biguanide nowadays. It is an oral anti-diabetic drug, in particular, used for type II diabetes mellitus patients accompanying obesity and insulin resistance [2]
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