Background: Allergic rhinitis, acute nasal congestion and sinusitis are one of the most common health problems and have a major effect on the quality of life. Several medications are used to improve the symptoms of such diseases in humans. Pharmaceutical pomade form containing Ephedrine (EPD) HCl, Naphazoline (NPZ) HCl, Antazoline (ANT) HCl, and Chlorobutanol (CLO) is one of them.

Objective: For these reasons, this study includes the development of spectrophotometric and chromatographic methods for the determination of EPD HCl, NPZ HCl, ANT HCl, and CLO active agents in the pharmaceutical pomade.

Method: In the spectrophotometric method, third-order derivative of the amplitudes at 218 nm n=5 and the first-order derivative of the amplitudes 254 nm n=13 was selected for the determination of EPD, ANT, respectively while NPZ was determined by the second derivative at 234 nm and n=21. Colorimetric detection was applied for assay analysis of CLO at 540 nm. Furthermore, a reverse phase high performance liquid chromatographic (RP- HPLC) method has been developed and optimized by using Agilent Zorbax Eclipse XDB C18 (75 mm x 3.0 mm, 3.5μm) column. The column temperature was 40°C, binary gradient elution was used and the mobile phase consisted of 15 mM phosphate buffer in distilled water (pH 3.0) and methanol, and the flow rate was 0.6 mL min^-1 and the UV detector was detected at 210 nm. The linear operating range was obtained as 11.97-70, 0.59-3, 2.79-30, and 2.92-200 μg mL^-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO respectively.

Results: The LOD values were found to be 3.95, 0.19, 0.92 and 0.96 μg mL^-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO in the spectrophotometric method, respectively. The linear ranges in the RP-HPLC method were 8.2-24.36 μg mL^-1, 0.083 - 0.75 μg/mL, 2.01-7.5 μg mL^-1 and 2.89-24.4 μg mL^-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO, respectively. The LOD values in the validation studies were 2.7, 0.025, 0.66 and 0.86 μg mL^-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO in RP-HPLC method respectively.

Conclusion: The results of the spectrophotometric and chromatographic methods were compared and no differences were found between the two methods.

背景：过敏性鼻炎，急性鼻充血和鼻窦炎是最常见的健康问题之一，对生活质量产生重大影响。几种药物被用来改善人类这种疾病的症状。包含麻黄碱（EPD）HCl，萘甲唑啉（NPZ）HCl，蒽唑啉（ANT）HCl和氯丁醇（CLO）的药用润肤剂就是其中之一。

目的：出于这些原因，这项研究包括开发用于测定药用润发油中EPD HCl，NPZ HCl，ANT HCl和CLO活性剂的分光光度法和色谱法。

方法：在分光光度法中，分别选择218 nm n = 5的振幅的三阶导数和254 nm n = 13的振幅的一阶导数分别测定NPZ和NPZ。 234 nm处的二阶导数，n = 21。比色检测用于540 nm处CLO的分析。此外，通过使用Agilent Zorbax Eclipse XDB C18（75 mm x 3.0 mm，3.5μm）色谱柱，已经开发并优化了反相高效液相色谱（RP-HPLC）方法。柱温为40°C，使用二元梯度洗脱，流动相由溶于蒸馏水（pH 3.0）的15 mM磷酸盐缓冲液和甲醇组成，流速为0.6 mL min ^-1并且在210nm处检测到UV检测器。对于EPD HCl，NPZ HCl，ANT HCl和CLO，线性工作范围分别为11.97-70、0.59-3、2.79-30和2.92-200μgmL ^-1。

结果：用分光光度法测定的EPD HCl，NPZ HCl，ANT HCl和CLO的LOD值分别为3.95、0.19、0.92和0.96μgmL ^-1。在RP-HPLC方法的线性范围为8.2-24.36微克毫升^-1，0.083 - 0.75微克/毫升，2.01-7.5微克毫升^-1和2.89-24.4微克毫升^-1为EPD盐酸，盐酸NPZ，ANT盐酸，和CLO分别。RP-HPLC方法中，EPD HCl，NPZ HCl，ANT HCl和CLO的验证研究中的LOD值分别为2.7、0.025、0.66和0.86μgmL ^-1。

结论：比较了分光光度法和色谱法的结果，两种方法之间没有差异。