purpose A sample set generator using Empower ® 3 software was created to automatically create chromatographic methods and sample set methods for UPLC ® methods for the validation of metoclopramide hydrochloride and its related substances. background The verification process for analytical methods is complex and demanding and involves many time consuming steps. Some verification steps involve the collection, review, and processing of data, as well as the calculation, approval, and final reporting of verification results. One of the key tasks is the stability test, which studies the effect of subtle changes in chromatographic parameters on the performance of the method to determine tolerance limits. In order to perform data collection for each validation test, multiple chromatographic methods must be carefully designed and created. However, manually designing, creating, and verifying such methods is cumbersome and error-prone. The Empower 3 Sample Set Generator simplifies the creation of instrument methods, method sets, and sample set methods by defining the range of variables required for testing. By automating these tasks, the generation of chromatographic methods and sample sequences is simplified while avoiding transcription errors. Laboratory efficiency and productivity have been improved by minimizing tedious tasks. The Empower 3 Sample Set Generator simplifies the creation of instrument methods, method sets, and sample set methods by defining the range of variables required for testing. In this article, we show how to use the Empower 3 sample set generator to automatically create chromatographic methods for the validation of UPLC method stability tests for metoclopramide hydrochloride and its USP-specified substances. solution Using software Empower 3 Method Validation Manager (MVM) verified metoclopramide hydrochloride USP and its related substances specified UPLC Method 1. MVM software simplifies the entire verification process from creation of verification methods to data collection, review, analysis, approval, and reporting of validation data in an application. The Empower 3 Sample Set Generator is used to simplify the stability tests necessary to create chromatographic methods. For stability, evaluate the following parameters: In the Empower 3 MVM project, we opened the sample set generator and loaded the stability verification test shown in Figure 1. The MVM test design introduced eight different instrument conditions into the Empower 3 sample set generator. Next, create the instrument method, method group, and sample set method in the sample set generator to run the stability test by: Using the Empower 3 sample set generator, we can automatically create instrument methods, method sets, and sample set methods for stability studies under different chromatographic conditions. The sample set method for stability testing (shown in Figure 2) was designed according to the experimental plan of the stability verification test, and the blank/standard solution injection, experiment name and method group for each run were set. When instrument conditions (such as flow rate or column temperature) change, a balancing step is added between the sample columns. These instrument methods are automatically created into the method group. Figure 2. Sample set method for stability testing generated using the Empower 3 sample set generator. This automated generation step allows us to quickly start the chromatogram run and is confident in the correctness of all the methods we create. In addition, the time required to create a chromatographic method is reduced by approximately 95% compared to the manual process. Figure 3 shows the chromatographic data collected for the stability test. Figure 3. Separation of metoclopramide and its USP-designated substances according to stability experiments. to sum up With the Empower 3 Sample Set Generator, users can automatically create instrument methods, method sets, and sample set methods simultaneously for chromatographic runs. Automated results show that transcription errors that can occur during manual processes can be eliminated while reducing the time required to generate chromatographic methods. This increases laboratory efficiency and, in turn, increases production efficiency. The Empower 3 Sample Set Generator can be used in any analytical laboratory and is used in conjunction with the Waters ACQUITY UPLC ® System to automatically create chromatographic methods (including method development and validation). references: Botanical Extract refers to the material extracted or processed from plants (all or part of plants) with appropriate solvents or methods, which can be used in the pharmaceutical industry, food industry, health industry, beauty industry and other industries. Botanical Extract ,Andrographolide Powder ,Kaempferol Powder, Isolated Soy Protein Meat Xi'an Double H Health Technology Co., Ltd , https://www.xadoubleh.com
■Column temperature: 45 ± 2.0 °C
■Flow rate: 0.6 ± 0.05 mL/min
■Wavelength: 270 ± 2 nm
1. Set the column temperature, flow rate and detection wavelength factor to the desired value
2. Set the required parameters for gradient separation
3. Set blank / standard solution and equilibration time requirements
4. Generate sample group method 
1. Maziarz M, McCarthy SM, Wrona M. Increasing Efficiency of Method Validation for Metoclopramide HCl and Related Substances with Empower MVM Software. Waters Application Note, 2014: 720005111en.