Analytics and spectra · Chromatography
“We need a new HPLC method, and scouting is eating up weeks of instrument time.”
HPLC method development with fewer scouting runs
A new HPLC method often starts with many runs across columns, pH values and gradients. CovaSyn narrows down column, pH and gradient up front from the properties of your analytes, simulates the separation and prepares transfer and validation. Your lab confirms the method with far fewer runs.
Starting point
When you need this
- A new API or intermediate has no stability-indicating method yet.
- A critical peak pair is not baseline-resolved, and the method needs improving.
- A method has to move to another instrument, another column or another site.
- Validation under ICH Q2(R2) lacks a plan, parameters and acceptance criteria.
Result
What you get
Starting method
A proposal for column chemistry, pH range, organic modifier and gradient, justified by the logD and pKa of your analytes.
Predicted retention and separation
Retention times and a simulated chromatogram, so critical peak pairs become visible before the first run.
Transfer and USP <621>
Converted conditions for other column dimensions or instruments and a check whether the changes stay within the allowed adjustments under USP <621>.
Validation plan
Validation parameters and a draft protocol under ICH Q2(R2), plus system suitability criteria.
Three ways
Yourself, together, or done for you
Run it yourself
Draw the molecule in the sketcher or use the tools through the CovaSyn MCP directly in Claude, ChatGPT or Cursor.
Go to MCPLearn it together
In a workshop your team learns how to answer questions like this with AI, cleanly and traceably.
See workshopsDone for you
We run the evaluation with our tools and deliver the finished report. Your expert reviews and signs off.
See Done-for-You
CovaSyn
The tools behind it
Deterministic calculations instead of guessed answers: the same tools we use for Done-for-You work are available to you directly.
Chromaopt
Column selection and equivalent columns, method suggestion, scouting plan, retention time prediction, simulation, method refinement, transfer and scaling, MODR, SST, USP <621>, validation parameters and protocol, plus greenness and cost assessment of a method.
Covachem
pKa values and a physicochemical profile, from which pH-dependent retention behaviour follows.
Covabasic
Structure validation, LogP and functional groups, so method planning starts from clean structures.
Audience
Who it is for
For analytical, QC and CMC teams at contract labs, CDMOs, generics manufacturers and specialty chemicals companies, wherever method development and transfer tie up instrument time and experts.
What the computation does not replace
- A prediction does not replace a measurement. Your lab confirms retention times and selectivity for critical pairs, as well as the influence of column batch and instrument.
- Matrix effects, unknown impurities and interactions with excipients are only covered as far as the structures are known.
Insights
Read on
HPLC Column Selection and Method Scouting
HPLC column selection chart and decision tree: match C18, phenyl-hexyl, PFP, HILIC or mixed-mode to logD and pKa. Scout fewer columns, start here.
Read articleRetention Time Prediction in HPLC Method Development
What retention time prediction in HPLC is actually good for, what it is not, and a worked impurity panel with real chromaopt_predict_rt outputs.
Read articleDesign Space, NOR and PAR: ICH Q8 Explained
ICH Q8 design space, NOR and PAR defined precisely, with real CovaDOE and CovaOPT tool output showing what a tighter spec costs you in operating window.
Read articleGreen Solvent Substitution Without Losing Solubility
Green solvent replacement in pharma: rank ICH Q3C Class 3 alternatives to DCM and chloroform by predicted solubility before you book lab time.
Read article
Questions
Common questions
How do I choose the right HPLC column for my method?
Polarity and ionisation of the analytes decide: logD and pKa show at which pH they are retained sufficiently and which stationary phase gives selectivity. As a rule of thumb, work at least 2 pH units away from the pKa so small pH variations do not shift retention. CovaSyn computes these values from structure and suggests suitable columns and alternatives.
Can HPLC retention times be predicted?
Yes, well enough to compare columns and gradients and spot critical pairs early. The method itself still needs measurements, because column batch, instrument and matrix shift the values.
Which changes to an HPLC method are allowed under USP <621>?
Within defined limits, USP <621> allows adjustments to parameters such as column length, particle size, flow rate, column temperature and gradient program without revalidation, as long as system suitability is still met. CovaSyn converts the adjusted conditions and checks whether they stay within those limits.
Who can develop an HPLC method for us?
CovaSyn does the computational method development as Done-for-You: you describe analytes, goal and instruments in the intro call, we agree on scope, and you typically receive the starting method and report within 5 working days once we have your data. Handled confidentially from the start. Your lab runs the confirmation.
What does HPLC method validation include?
Under ICH Q2(R2), depending on the purpose of the method, typically specificity, linearity and range, accuracy, precision, detection and quantitation limits, and robustness. CovaSyn compiles the relevant parameters and drafts a protocol that your expert adapts and approves.
Can I run the method development myself?
Yes. In the sketcher you draw your analytes and see core data instantly; the chromatography tools are available through the CovaSyn MCP directly in your AI assistant.
Analytics and spectra
Related problems we solve
Next step
Tell us about your separation problem.
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.