Stability-indicating methods for the determination of olanzapine in presence of its degradation products

Abstract

KEYWORDSSimple, sensitive and precise spectrophotometric and chemometric stability indicating techniques were adopted for Olanzapine (OLA) determination in presence of its degradation products over a concentration range of 0.002-0.02 mg/mL. The spectrophotometric technique involves six methods; first method is first derivative (D1) spectrophotometric one, which allows the determination of OLA in presence of its acidic and alkaline degradation products at 261.2 and 260.6 nm with mean percentage recoveries of 99.90±0.48 and 99.95±0.67, respectively. While second derivative spectrophotometry (D2) was used for determination of drug in presence of alkaline degradation products. Second method is firstderivative of the ratio spectra (DR1) for determination of OLA in presence of its acidic and alkaline degradation products at 267.9 and 251.6 nm, respectively with mean percentage recoveries of 99.81±0.64 and 100.53±1.11, respectively. The third method is pH-induced difference method for determination of OLA in presence of its acidic and alkaline degradation products; with mean percentage recoveries 100.09±0.06 and 99.77±0.78, respectively. Fourth method is the Q-analysis (absorption ratio) method, which involves the formation of absorbance equation at 296.3 nm (isosbestic point) and 271 nm (λmax of OLA) for the determination of OLA in presence of its acidic degradation products. The mean percentage recovery is 100.07±1.51. Fifth method based on dual wavelength selection was developed for the determination of OLA in presence of its acidic degradation products with mean percentage recovery of 100.36±0.69. Sixth method based on simple mathematic algorithm by the bivariate calibration was also used for the determination of OLA with the mean percentage recovery of 101.72±1.10. The second technique is chemometrics, which includes determination of OLA in presence of its acidic degradation products using multivariate calibration methods (the classical least squares (CLS), principle component regression (PCR) and partial least squares (PLS)) using the information contained in the absorption spectra.Olanzapine Q-absorbance Chemometrics Dual wavelength Bivariate calibration Derivative spectrophotometer

Universal procedures for spectrophotometric determination of anticoccidial drugs; application to multi-ingredient veterinary formulation and computational investigations for multivariate analysis

“…2021 -European Journal of Chemistry -CC BY NC -DOI: 10.5155/eurjchem.12.4.368-376.2144 For both PLS-2 and PCR, the concentration residuals were plotted against the actual concentrations of the prepared mixtures (Figures 7 and 8), and the residuals for all samples were found to be randomly distributed around zero [25][26][27][28][29][30][31][32][33]. The average recoveries of each drug using PLS-2 and PCR methods are summarized in Table 2.…”

“…The validation set is composed of 5 laboratory-prepared mixtures containing different proportions of AMP, SQX, and DVD (Table 1). In addition, the concentrations of AMP, SQX, and DVD in the veterinary formulation extract were calculated using the optimized PLS-2 or PCR calibration model after being recorded in the same specified lambda range [25][26][27][28][29][30][31][32][33].…”

Different spectrophotometric and TLC-densitometric methods for determination of olmesartan medoxomil and hydrochlorothiazide and their degradation products

“…It has a lot of advantages like, high productivity with minimum cost, improved precision and truthful of results, increased affirmation for carrying out laboratory operations, easier validation of the variable steps of an analytical technique [46]. Wide applications of multivariate calibretion methods were seen for different multi-components mixtures as in [47][48][49][50][51][52].…”

Purity assessment and determination of sertaconazole in bulk and pharmaceutical formulations based on spectrophotometric and chromatographic approaches

“…Derivative spectrophotometry is considered to be an ideal stability indicating method that quantifies the standard drug alone and also resolves its degradation products as reported for antipsychotic drug, olanzapine [14]. A rapid, simple and low cost spectrophotometric method based on measuring the peak amplitude of 1 D at 290 nm ( Figure 5) was developed for determination of SER in presence of its acidic degradates (Corresponding to zero crossing of the degradates).…”