Development And Evaluation Of Simple Spectrophotometric Methods For The Simultaneous Determination Of Alogliptin Benzoate Metformin Hydrochloride And Melamine

Document Type : Original Article

Authors

1 Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.

2 Chemistry Department, Faculty for Girls, Ain Shams University, Cairo, Egypt

3 Pharmaceutical Chemistry Department, Nahda University , Egypt

Abstract

For an analyst, quantitative determination of a ternary combination with strongly overlapped spectra is a difficult task. The resolution and quantification of a ternary combination consisting of alogliptin benzoate, metformin HCl, and metformin impurity; melamin were achieved without the requirement for any preliminary separation processes by manipulating spectral data of this overlap using simple spectrophotometric techniques. For the determination of the three components, two straightforward, sensitive, and reproducible procedures were developed. Combining many spectrophotometric techniques, method (A) identifies the three components under investigation; Zero order spectrophotometric analysis was used to identify alogliptin benzoate (0D) at 276 nm, metformin HCl and melamin were determined by ratio difference spectrophotometric method; using 5 µg mL-1 of alogliptin benzoate as a divisor and measuring the difference in absorbance between 226.6, 240nm and 207.6, 255.8nm for determination of metformin HCl and melamin respectively. In method (B), the ratio spectra were centred using the mean approach, with the mean amplitudes at279.2, 236.2, and 232.2 nm were used for the estimation of alogliptin benzoate, metformin HCl and melamin, respectively. The methods' accuracy, precision, and selectivity have all been validated in accordance with ICH recommendations. The techniques have also been applied to Westirizide® tablets that include both Alogliptin benzoate and Metformin HCl, and the results showed that there was no interference from additives. When these approaches were contrasted with the described one, no significant difference was discovered.

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