Analysis of loratadine and its related substances using the ACQUITY UPLC H-CLASS system

aims

The HPLC method for the analysis of loratadine was successfully converted to the ACQUITY UPLC ® H-CLASS system and converted to the UPLC ® optimization method.

background

Testing of drugs and drugs is usually done by detecting impurities and related substances and active substances (API) to ensure the safety and effectiveness of the drug. The US Pharmacopoeia's legal test for these substances is usually a long column HPLC with a longer run time. For loratadine and loratadine tablets (this is an antihistamine for the treatment of allergies), for the analysis of related substances (RS), the USP method uses a 4.6mm x 15cmL7 column at a flow rate of 1.0mL/min, etc. Degree elution, time is about 20min. The second method for the analysis of loratadine-related substances (designated as test 2) was carried out by a different integrated approach using a 4.6 mm x 25 cm L1 column with a gradient of 1.2 mL/min for 50 min to separate one of them. Kind of impurities. For a laboratory, the reduction in analysis time will significantly reduce the cost of analysis in the laboratory.

The ACQUITY UPLC H-CLASS system approach was developed approximately five times faster than current HPLC methods, and comparable or even more optimized data results were obtained. This system provides an ideal solution for the USP legal HPLC method in the laboratory, opening the way to exploring how to transform existing methods into more cost-effective UPLC methods.

solution

The method provided by USP uses a traditional HPLC system (the Alliance ® HPLC system to configure a 2998 photodiode array detector) in strict accordance with the regulations. The entire analysis runs on the ACQUITY UPLC H-CLASS system. Comparing the results of these two methods (retention time reproducibility, associated retention time and impurity peaks) demonstrates that the ACQUITY UPLC H-CLASS system is equivalent to the performance of traditional HPLC in performing such detection methods, and even slightly better. .

The HPLC method can be seamlessly converted to a UPLC method using the instrument's own ACQUITY UPLC Column Conversion Calculator. Using this new calculation method, the entire sample set can be analyzed, and the results (retention time reproducibility, associated retention time and impurity peaks) are compared with HPLC results: the run time can be significantly reduced, and the 20 min of isocratic elution is shortened. By 4 minutes, the results obtained by running the HPLC method on the ACQUITY H-CLASS system were more optimized than those obtained on a conventional HPLC system (Figure 1).

Figure 1. Comparison of chromatograms of loratadine and its related substances obtained by running HPLC on the Alliance HPLC system with HPLC and UPLC running on the ACQUITY UPLC H-CLASS system.

summary

The HPLC method used to analyze loratadine and its related materials was successfully reproduced on the Waters ACQUITY UPLC H-CLASS system. The data obtained on this system is identical to the Alliance HPLC system and meets the requirements of the USP method.

With the aid of the ACQUITY UPLC Column Conversion Calculator, the detection method can be converted to a UPLC method on the ACQUITY UPLC H-CLASS system. This new UPLC method is about 5 times faster than current HPLC methods, with the same even more optimized data. Get high quality data faster, increase lab productivity and reduce the cost of individual samples.

The Waters ACQUITY UPLC H-Class System provides an ideal solution for laboratories performing USP statutory HPLC methods, opening the way to exploring how to transform existing methods into more cost-effective UPLC methods.

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