Different aspects in manipulating overlapped spectra used for the analysis of trimebutine maleate and structure elucidation of its degradation products

Abstract

Abstract Background Four rapid, accurate, and validated stability-indicating spectrophotometric methods have been described in the present work for the analysis of trimebutine maleate (TM) in existence of its degradation products in its authentic form and in pharmaceutical formulations excluding any separation steps. Results These methods were a dual-wavelength (DW) method which allows the determination of TM in existence of its degradation products at 243 nm and 269 nm, second derivative (D 2) method measured at peak amplitude at 268 nm, ratio difference (RD) method at 242 nm and 278 nm, and constant center coupled with spectrum subtraction (CC-SS) method at 242 nm and 278 nm versus 278 nm. By applying the suggested methods, TM could be quantified in the range of 5.0–60.0 μg/mL with percentage recoveries 99.97 ± 0.40, 100.36 ± 0.58, 99.90 ± 0.42, and 100.15 ± 0.45 for DW, D 2, RD, and CC-SS methods, respectively. International Conference on Harmonization guidelines were followed for validation of the described methods, and the application of laboratory-prepared mixtures along with different pharmaceutical drugs including the target drug showed favorable results without any contribution from additives. Conclusions Statistical comparison was used to compare the proposed and official methods, and satisfactory results for both accuracy and precision were obtained. The results confirm the applicability of the suggested methods for the determination of TM in quality control laboratories.

Keywords

• Degradation products
• Trimebutine maleate
• UV stability-indicating spectrophotometric methods