Recommended and verified stability indicating GC–MS procedures for green separation of quaternary mixture of naphazoline, ephedrine, methylparaben, and naphazoline impurity

Abstract

A GC–MS analytical method, for the estimation of a vasoconstrictive drug combination of naphazoline nitrate and ephedrine hydrochloride, for allergic rhinitis treatment, in the presence of a photo-absorptive anti-bacterial additive (methylparaben) and naphazoline impurity (1-naphthaleneacetic acid), is offered concerning the cutting-edge trend in drug analysis. Environment, cost, and time factors are considered mainly in the establishment of the proposed method. The mixture is analyzed on the highly polar GC stationary phase of (5 % Phenyl Methyl) Silox. The two ions of m/z 209 and 58 were nominated to estimate naphazoline nitrate and ephedrine hydrochloride, correspondingly. Reduction in sample size is achieved by preparing mixture solutions in different drug ratios for calibration curves construction, using ethanol as a typical green solvent referring to its non-toxicity and renewability. The novel and validated chromatographic method is established for the analysis of the two drugs, concurrently in pure form ensuing optimum linearity in the range of 5–30 ppm (r = 0. 99988) for naphazoline nitrate and 15–45 ppm (r = 0. 98865) for ephedrine hydrochloride. The retention times (Rt) of naphazoline nitrate and ephedrine hydrochloride, methylparaben, and 1-naphthaleneacetic acid are 8.7, 3.2, 3.9 & 6.9 min, respectively. Statistical analyses are performed for the validated method, proving the reliability and robustness of the results. The method is successfully applied to analyze the drugs in Deltarhino nasal solution. The method is highly recommended in the quality assurance assessment of the drugs’ raw materials and dosage form. The new GC–MS method is preferred over the old described HPLC one concerning greenness characteristics and reduction of sample size when scanning the greenness characteristics using AGREE and GAPI tools.