Stability-Indicating Methods for the Determination of Erdosteine in the Presence of its Acid Degradation Products

Abstract

Abstract Four accurate, sensitive, and reproducible stability-indicating methods for the determination of erdosteine in the presence of its acid degradation products are presented. The first method involves processing the spectra by using a first-derivative method at 229 nm in a concentration range of 10–70 μg/mL. The mean percentage recovery was 100.43 ± 0.977. The second method is based on ratio-spectra first derivative spectrophotometry at 227.4 and 255 nm over a concentration range of 10–70 μg/mL. The mean percentage recovery was 99.65 ± 1.122% and 100.02 ± 1.306% at 227.4 and 255 nm, respectively. The third method utilizes quantitative densitometric evaluation of the TLC of erdosteine in the presence of its acid degradation products, and uses methanol–chloroform–ammonia (7 + 3 + 0.01, v/v/v) asthe mobile phase. TLC chromatograms were scanned at235 nm. This method analyzes erdosteine in a concentration range of 2.4–5.6 μg/spot, with a mean percentage recovery of 100.03 ± 1.015%. The fourth method is HPLC for the simultaneousdetermination of erdosteine in the presence of its acid degradation products. The mobile phase consists of water–methanol (65 + 35, v/v). The standard curve of erdosteine showed good linearity overa concentration range of 10–80 μg/mL,with a mean percentage recovery of 99.90 ± 1.207%. These methods were successfully applied to the determination of erdosteine in bulk powder, laboratory-prepared mixtures containing different percentages of the degradation products, and pharmaceutical dosage forms. The validity of results was assessed by applying the standard addition technique. The results obtained agreed statistically with those obtained by a reported method, showing no significant differences with respect to accuracy and precision.