應用兩種磺酞（Sulphonphthalein）酸性染劑檢測奧氮平（Olanzapine）製劑之簡易且靈敏度高的分光光度法   全文下載

Simple and Sensitive Spectrophotometric Determination of Olanzapine in Pharmaceutical Formulations Using Two Sulphonphthalein Acid Dyes

本實驗研發兩種簡易、靈敏度高且不須萃取之分光光度法檢測奧氮平（Olanzapine, OLP）純品及製劑。將奧氮平分別與兩種磺?酸性染劑-- 溴甲酚紫（Bromocresol Purple, BCP）及溴瑞香草酚藍（Bromothymol blue, BTB），合成黃色離子對複合物，分別於波長 405 nm 和 410 nm 時測定其最大吸光值。兩種複合物的化學計量比皆為1：1，其條件穩定常數（KF）亦已算出。反應條件皆已最適化以獲得最高顏色飽和度。溴甲酚紫（BCP）和溴瑞香草酚藍（BTB）濃度範圍分別為1.0-10.0 以及1.0-8.0 μg/mL時符合比爾吸收定律。各種實驗參數均經評估，檢驗結果亦經統計數據確效。本方法可成功地應用於奧氮平純品及其製劑之分析，且不受製劑中一般賦形劑的干擾。"

Two simple, sensitive and extraction-free spectrophotometric methods have been developed for the determination of olanzapine (OLP) both in pure form and in pharmaceutical formulations. The methods are based on the formation of yellow coloured ion-pair complexes between OLP and two sulphonphthalein acid dyes, bromocresol purple (BCP) and bromothymol blue (BTB) with absorption maximum at 405 nm and 410 nm for BCP and BTB, respectively. The stoichiometry of the complex in either case was found to be 1: 1 and the conditional stability constant (KF) of the complexes has also been calculated. Reaction conditions were optimized to obtain the maximum colour intensity. Beer’s law was obeyed in the concentration ranges of 1.0 - 10.0 and 1.0 - 8.0 μg/mL with BCP and BTB, respectively. Various analytical parameters have been evaluated and the results have been validated by statistical data. The proposed methods have been applied successfully to the analysis of OLP in pure form and in its dosage forms and no interference was observed from common excipients present in pharmaceutical formulations.