Application of two chemometric methods for the determination of imipramine, amitriptyline and perphenazine in content uniformity and drug dissolution studies.
Double-divisor spectra derivative and partial least squares methods were developed for content uniformity and dissolution tests in binary or ternary mixtures. The simultaneous determinations of perphenazine (PER) combined with amitriptyline hydrochloride (AMI) and/or imipramine hydrochloride (IMI) have been accomplished using the information of the absorption spectra of appropriate solutions. The double-divisor method is based on the use of the first derivative of the ratio spectrum obtained by dividing the absorption spectrum of the ternary mixture PER-AMI-IMI by a standard spectrum resulted from the addition of two of the three analytes in equal concentrations. The concentration of each component is then determined from their respective calibration graphs established by measuring the ratio derivative analytical signal at a specific wavelength. In this method, the linear determination ranges were of 3.65-18.24 microg/mL for PER, 4.32-21.60 microg/mL for AMI, and 4.83-24.19 microg/mL for IMI. The results were compared with those obtained by partial least squares multivariate calibration (PLS) method pre-treated by a wavelet compression-orthogonal signal correction (W-OSC) filter in zero-order derivative spectra. The calibration model was evaluated by internal validation (cross-validation) and by external validation over synthetic mixtures, content uniformity and dissolution tests. According to the dissolution profile test more than 95% of the three substances were dissolved within 10 min. The results from both techniques were statistically compared with each other and can be satisfactorily used for quantitative analysis and dissolution tests of multicomponent tablets.
Markopoulou
Catherine K
CK
Laboratory of Pharmaceutical Analysis, School of Pharmacy, Aristotelian University, 54124 Thessaloniki, Greece.
Malliou
Eleftheria T
ET
Koundourellis
John E
JE
D000639:Amitriptyline / Q000032:analysis* / Q000592:standards; D014150:Antipsychotic Agents / Q000032:analysis* / Q000592:standards; D002138:Calibration; D004338:Drug Combinations; D004339:Drug Compounding / Q000592:standards; D007099:Imipramine / Q000032:analysis* / Q000592:standards; D008956:Models, Chemical; D010546:Perphenazine / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012995:Solubility; D012996:Solutions; D013053:Spectrophotometry; D013607:Tablets
D014150:Antipsychotic Agents; D004338:Drug Combinations; D012996:Solutions; D013607:Tablets; D000639:Amitriptyline; D010546:Perphenazine; D007099:Imipramine