Valtrate is the main drug quality control for the qualitative and quantitative analysis of Valerian medicines in the Chinese Pharmacopoeia 2010. However, valtrate is unstable under some conditions. We, for the first time, systemically evaluated the stability of two bath reference standards (RS) by high performance liquid chromatography coupled with a triple quadrupole mass spectrometer (HPLC-MS/MS). The forced degradations of valtrate were performed to evaluate its optimal storage, transportation and experiment conditions according to ICH guideline. The developed HPLC method was validated to determine the degradation products. Valtrate RS was sensitive to alkaline and thermal conditions, but it was relatively stable under acidic, oxidation and photolysis conditions. A total of nine degradation components were identified under alkaline hydrolysis (N1-N4) and thermal degradation (B1-B5). The information obtained in this work would be valuable to minimize the decomposition of valtrate during the processes of preparation, storage, distribution and utilization. It was highly suggested to store valtrate with a single dose packing in brown closed ampoule at -20℃. Under the above-mentioned storage condition, valtrate could be stable for up to 3 years.
A decade ago, only two hormones, parathyroid hormone and 1,25(OH)2D, were widely recognized to direct-ly affect phosphate homeostasis. Since the discovery of fibroblast growth factor 23 (FGF23) in 2000 (1), our understanding of the mechanisms of phosphate homeostasis and of bone mineralization has grown exponentially. FGF23 is the link between intestine, bone, and kidney together in phosphate regulation. However, we still do not know the complex mechanism of phosphate homeostasis and bone mineralization. The physiological role of FGF23 is to regulate serum phosphate. Secreted mainly by osteocytes and osteo- blasts in the skeleton (2-3), it modulates kidney handling of phosphate reabsorption and calcitriol produc-tion. Genetic and acquired abnormalities in FGF23 structure and metabolism cause conditions of either hyper-FGF23 or hypo-FGF23. Hyper-FGF23 is related to hypophosphatemia, while hypo-FGF23 is related to hyperphosphatemia. Both hyper-FGF23 and hypo-FGF23 are detrimentalto humans. In this review, we will discuss the vathovhvsiology of FGF23 and hvver-FGF23 related renal vhosvhate wasting disorders (4).