Method validation of pyridoxine hydrochloride in neurorubin by high performance liquid chromatography / Монголын эм зүй, эм судлал

ABSTRACT

Introduction@#Pyridoxine hydrochloride is least expensive supplement named as a vitamin 6¹. Pyridoxal kinase is the enzyme that produces pyridoxal phosphate which known as pyridoxine hydrochloride that occurs in the human body. Diabetes, age and neurodegenerative diseases complications can be reduced by pyridoxine hydrochloride^{2 3}. Quantification of pyridoxine hydrochloride in neurorubin as an injection form was developed by high performance liquid chromatography (HPLC) method. Further, the proposed method was validated for linearity, precision (system precision, method precision, intermediate or inter-day precision), and accuracy, stability in analytical solution, system suitability and roughness. The developed method exhibited the best results in terms of the aforesaid validation parameters. The method was found to be selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of pyridoxine hydrochloride in injection.@*Goal@#The aim of this study was to develop the validation method of pyridoxine hydrochloride in injection. @*Material and Methods@#</br>I) Test Article. As a test article neurorubin injection was produced by Tsombo Farm LLC. The standard pyridoxine hydrochloride was supplied from Sigma Aldrich Co. </br>II) Reagents and Equipment. The reagents were HPLC grade acetonitrile methanol, and purified water. Balance, and micropipette used as equipment. Shimadzu HPLC (LC20AD) was used as the analytical instrument and the analysis conditions were as follows (Table 1). @*Results@#The calibration curves for pyridoxine hydrochloride were made by plotting the peak area versus the concentration for each analyte using regression analysis. Each calibration curve was obtained using six levels of concentrations in the range 12.5-100 pg/mL. The linear correlation coefficient (R²) for all calibration curves was higher than 0.995 for all analytes. The LOD and LOQ for pyridoxine hydrochloride were in 15.29 pg/mL and 46.33 pg/mL, respectively.</br> Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low, middle and high concentrations. The RSD values of both repeatability and intermediate precision were below 1.669 % and 1.678 % the accuracy remaining between 95.25 to 102.775 %. The resulting accuracy data were satisfactory for the quantitative analysis of pyridoxine hydrochloride in neurorubin injection.</br> The results of summarized in table 2, 3, 4. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of pyridoxine hydrochloride, as part of the quality assessment of products containing in injection.