AN195 Acclaim PA柱检测盐酸维拉帕米纯度.pdf

INTRODUCTION Verapamil-based medications are prescribed for several heart and blood pressure indications. The fast-acting formulations (verapamil hydrochloride and Isoptin®) are taken for angina, as well as irregular heartbeat and high blood pressure. The United States Pharmacopeia (USP®) has a monograph method to determine verapamil hydrochloride purity. This method separates verapamil hydrochloride and verapamil-related compound B using HPLC with a C18 (USP designation L1) column.There is a recent proposal to revise the method by using a L60 column to determine verapamil hydrochloride and verapamil-related compounds B and D. The existing method can not determine compound D under the prescribed eluent. The proposed method is time consuming (61 min), and requires a special column. 2 In this application note, we describe a new method for the fast determination of verapamil hydrochloride and verapamil-related compounds A, B, and D, using a polar-embedded reversed-phase column, the Acclaim® PolarAdvantage (PA). The new method requires only about half the time of the proposed USP monograph method, provides signifcant eluent and therefore cost savings, and meets the resolution requirement.