Using Existing Analytical Methods in the Latest Instruments

At first glance, an updated model of the same instrument is a sound choice if you wish to continue using existing analytical methods But technology is always advancing and system performance aspects, such as instrument stability and ease of use, change in ways not apparent in the data. By upgrading to i-Series Plus, you retain compatibility with existing systems, but also acquire substantial improvements in the reliability and stability of your analytical results. i-Series Plus supports the transfer of analytical methods as it relates to both system capacity and software control, and also provides the optimum analytical environment for increasing the speed of analytical methods and other areas of method development.

 

Supporting Analytical Method Migration Operations at the Hardware Level
 

i-Series Plus system capacity is highly compatible with other systems, and analytical methods can be transferred with ease from competitor systems. An optional kit can also be used to make i-Series Plus compatible with Shimadzu's previous LC-2010 series, reducing the work involved in migrating existing analytical methods, and supporting the smooth startup of operations following instrument installation. Based on a given set of analytical results, the chromatograms below show compatibility between a standard i-Series Plus configuration and a competitor's system, and between the a standard i-Series Plus configuration and a previous Shimadzu instrument (LC-2010) when using the optional kit. The chromatograms show that i-Series Plus has been designed with a high level of compatibility built into its hardware.

 

Method transfer from previous Shimadzu LC-2010HT to Prominence-i
  Method transfer from other vendor's system to Prominence-i

 

Compatibility Through Software Control (ACTO)
 

Say you want to migrate an existing method unaltered but also develop methods using the latest equipment available in the development laboratory. In this situation, the ACTO (Analytical Condition Transfer and Optimization) function can be used. ACTO is the general name given to method transfer/migration tools supplied by Shimadzu. It can be used to adjust gradient start times and allows analysis to be performed without worrying about the effects of piping volume. ACTO allows you to adjust gradient timings via simple software settings without having to edit the gradient program itself. As shown below, similar analytical results can be obtained using a method created for a previous system with a larger system capacity and for Prominence-i. This gradient start time adjustment function can be used with all i-Series Plus models.

 

 

Retention Time Difference (%)

 
 
Without ACTO Adjustment With ACTO Adjustment
1 -3.13% 0.31%
2 -2.63% -0.39%
3 -2.08% -0.38%
4 -1.71% -0.17%
5 -1.19% -0.10%

 

 

Utilizing ACTO for US Pharmacopeia-Compliant Method Migration
 

Maintaining method compatibility during gradient analysis can be difficult due to differences in gradient delay volumes between models. USP <621> allows the use of a gradient start time adjustment function (ACTO) to adjust the initial hold time without the need for revalidation (when adjustments are required, the column packing may be changed [maintaining the same chemistry], the duration of an initial isocratic hold may be changed [when prescribed], and/or dwell volume adjustments can be made). Even when instrument models have different gradient delay volumes, analysis can be performed in accordance with the US Pharmacopeia without replacing piping, etc

 

 

Comparison of Retention Time Difference (%) With and Without ACTO Adjustment

Component Without ACTO Adjustment With ACTO Adjustment
1. impurity A 1.3% 1.1%
2. impurity B 2.7% 0.3%
3. impurity C, D 3.1% 0.2%
4. Montelucast Sodium 2.7% -0.1%
5. impurity E 2.8% -0.1%
6. impurity F 2.5% -0.3%

 

i-Series Plus for Method Development
 

i-Series Plus can now be utilized by development departments for analytical methods since it is compatible with the Nexera-i MT, which performs HPLC and UHPLC analysis on a single system, and is also compatible with the Method Scouting Solution software that supports method development. Using i-Series Plus to perform operations from development to quality control precludes the need to worry about differences in models, and analytical methods can be developed more efficiently.

 

Transfer Methods with a Single Button Operation: ACTO Function
 

Once a UHPLC method has been transferred to HPLC, the flow rate and gradient program must be calculated according to the column size. The method transfer/migration support tool ACTO allows you to simply open an existing method file in LabSolutions and specify the column, and the software will automatically calculate the appropriate settings. The results can also be output directly as a LabSolutions method, so the calculated results do not need to be transcribed and there are no concerns over transcription errors.

 

 

A cephem-based antibiotic was analyzed by UHPLC with the Nexera-i MT. The method was then converted to an HPLC method with ACTO (1). This illustrates how an HPLC method created by the Nexera-i MT can be migrated unaltered to Prominence-i or a competitor's system (2). With the Nexera-i MT, a single system can be used for both method development by rapid UHPLC and conversion to an HPLC method.