Photodegradation of Methylcobalamin and Its Determination in a Commercial Formulation

Abstract

Chamle et al.: Photodegradation of Methylcobalamin using RP-HPLC and MS/MS Methylcobalamin is a highly photolabile and unstable molecule and hence, studies regarding photodegradation of methylcobalamin were carried out. In order to investigate the stability studies, the drug was subjected to photodegradation by exposing it to different light conditions in the validated photostability chamber as per ICH Q1B guideline. The drug was found to be less degraded in the blue light and was more prone to degradation under fluorescent light. Validated stability indicating liquid chromatography method was used for separating the methylcobalamin and its degradation products. The methylcobalamin peak with a retention time of 2.978 min was observed to decrease with a commensurate increase in a degradant peak at 4 min. The observed degradant peak was suspected to be hydroxocobalamin and was further confirmed by molecular weight determination. The fractions collected from high performance liquid chromatography were later injected into mass detector to determine the mass of the degradation products, which was found to be 665.78 amu.

Vitamin B12 in Foods, Food Supplements, and Medicines—A Review of Its Role and Properties with a Focus on Its Stability

“…CNCbl degradation in commercial parenteral preparations containing thiamine and pyridoxine, after two months of their light-protected storage at 40 • C, was additionally confirmed by Monajjemzadeh et al By evaluating the CNCbl stability after 5 days at 55 • C in experimentally prepared parenteral formulations containing different CNCbl, thiamine, and pyridoxine combinations, they confirmed the CNCbl stability in a single-ingredient CNCbl solution as well as in combination with pyridoxine (97%) and its degradation in solutions with thiamine (79%) and especially in combination with thiamine and pyridoxine (41%) [150]. Recently, there is an increasing number of studies that highlight the photolability of MeCbl in liquid dosage forms and the need for its light-protected storage and proper stabilization [212][213][214].…”

A Validated Reversed-phase High-performance Liquid Chromatography Analytical Method for the Analysis of Methylcobalamin in Bulk Drugs and T-Dosage Formulation

“…[1][2][3] According to the literature review, high-performance liquid chromatography (HPLC) should be considered as a technique for estimating methylcobalamin in individual or combined t dosage formulations. [4][5][6][7][8][9][10][11][12][13] However, the stated technique has the disadvantages of a long runtime and being less cost-effective due to the high proportion of organic phase. As a result, the HPLC technique for determining methylcobalamin in combined t and bulk dose forms is an accurate, precise, simple, specific, and cost-effective technology.…”