We already have Waters isocratic hplc system without auto sampler being used for the routine analysis of the Drugs . Pl suggest us the full equipment configuration for the purpose.
There really is no "best" configuration until you identify the exact samples you wish to run. "Pharmaceuticals" is too broad a group as some require specialize detectors which are not addressed in my response.
As a consultant to the industry with 20+ years of experience, I would offer a few general recommendations. These may or may not be applicable to every sample you intend to analyze, but in my opinion would make up a very good general purpose method development and analysis system.
PUMP: Must be gradient capable. Isocratic pump is of little value in pharmaceutical analysis. For most applications, purchase a quaternary pump (low pressure), not a high pressure binary pump. Low pressure pump with access to multiple bottles (e.g. 4) is always more useful and when properly optimized (tubing and mixer), has similar performance to a modern high pressure binary system. Pressure max not critical, but 600 bars should be plenty! *The pump is the most important component of an HPLC system! Bad choice in pump = all of your time spent trying to establish steady flow rates.
Degasser: Either a Helium sparging system or high quality electronic in-line vacuum, multi-channel degasser module is required to maintain pump flow ripple at very low levels and reduce pump cavitation or check valve problems. Do not use vacuum filtration or sonication for degassing (bad advice/poor quality solutions). Mobile phase degassing is Required for both NP and RP analysis. *I prefer models which have degasser pumps which run in "continuous mode" due to their better baseline stability and lower drift over time. Note: For some GPC applications, the older style vacuum degassers with PTFE membranes are preferred (esp where THF is used).
Column Oven: The ability to control column temperature is critical. Repeatability will be poor without one. *Find one that properly fits the columns you plan on using. Ideally, it should heat and cool, but really just needs to maintain and control temperature to start with.
Autoinjector: 0.1 to 100 ul range. Ideally, look for one with a true "flow through needle and injector pump" flushing because it will not need a wash vial. Far less carryover and better performance.
Sampler: A manual injector is fine for many applications, but an automated sampler with 100 vial positions is far more useful for automated analysis.
Detector: Absolutely must purchase a Diode Array Detector (PDA/DAD). IMHO: Single or even multi-wavelength units are a mistake and waste of money. You will need the 2D scan feature of the DAD to view the spectra of each individual peak for help in identifying peaks, observing co-elution, predicting "purity" and also for troubleshooting. You will not regret it! You can not do proper method development with a single wavelength detector.
Software (CDS): Be sure and have someone with lots of practical experience demo and test a few of the popular chromatography data systems before purchase.
Optional, Automated Column Selector: If you plan on developing many methods, running several types of compounds using existing methods or screening new samples to find methods, then a high quality automated column selection system is a must. Look for one with more column positions than you think you will need (to test new columns with). 5, 7 or 9 column capacity with or without full temperature control of the column compartment.
Not Optional: Training in how to operate and use everything for everyone. No one comes with the "knowledge". It has to be learned from hands-on experience, practical use and a great deal of time solving real world problems. This process takes many years to learn the basics. This is the one area that most clients skip or leave no budget for. Without proper training, your newly purchased hardware is worthless.
There really is no "best" configuration until you identify the exact samples you wish to run. "Pharmaceuticals" is too broad a group as some require specialize detectors which are not addressed in my response.
As a consultant to the industry with 20+ years of experience, I would offer a few general recommendations. These may or may not be applicable to every sample you intend to analyze, but in my opinion would make up a very good general purpose method development and analysis system.
PUMP: Must be gradient capable. Isocratic pump is of little value in pharmaceutical analysis. For most applications, purchase a quaternary pump (low pressure), not a high pressure binary pump. Low pressure pump with access to multiple bottles (e.g. 4) is always more useful and when properly optimized (tubing and mixer), has similar performance to a modern high pressure binary system. Pressure max not critical, but 600 bars should be plenty! *The pump is the most important component of an HPLC system! Bad choice in pump = all of your time spent trying to establish steady flow rates.
Degasser: Either a Helium sparging system or high quality electronic in-line vacuum, multi-channel degasser module is required to maintain pump flow ripple at very low levels and reduce pump cavitation or check valve problems. Do not use vacuum filtration or sonication for degassing (bad advice/poor quality solutions). Mobile phase degassing is Required for both NP and RP analysis. *I prefer models which have degasser pumps which run in "continuous mode" due to their better baseline stability and lower drift over time. Note: For some GPC applications, the older style vacuum degassers with PTFE membranes are preferred (esp where THF is used).
Column Oven: The ability to control column temperature is critical. Repeatability will be poor without one. *Find one that properly fits the columns you plan on using. Ideally, it should heat and cool, but really just needs to maintain and control temperature to start with.
Autoinjector: 0.1 to 100 ul range. Ideally, look for one with a true "flow through needle and injector pump" flushing because it will not need a wash vial. Far less carryover and better performance.
Sampler: A manual injector is fine for many applications, but an automated sampler with 100 vial positions is far more useful for automated analysis.
Detector: Absolutely must purchase a Diode Array Detector (PDA/DAD). IMHO: Single or even multi-wavelength units are a mistake and waste of money. You will need the 2D scan feature of the DAD to view the spectra of each individual peak for help in identifying peaks, observing co-elution, predicting "purity" and also for troubleshooting. You will not regret it! You can not do proper method development with a single wavelength detector.
Software (CDS): Be sure and have someone with lots of practical experience demo and test a few of the popular chromatography data systems before purchase.
Optional, Automated Column Selector: If you plan on developing many methods, running several types of compounds using existing methods or screening new samples to find methods, then a high quality automated column selection system is a must. Look for one with more column positions than you think you will need (to test new columns with). 5, 7 or 9 column capacity with or without full temperature control of the column compartment.
Not Optional: Training in how to operate and use everything for everyone. No one comes with the "knowledge". It has to be learned from hands-on experience, practical use and a great deal of time solving real world problems. This process takes many years to learn the basics. This is the one area that most clients skip or leave no budget for. Without proper training, your newly purchased hardware is worthless.
I´d like to underline what Bill said about training on how to operate and use everything. He has much more experience than I do in the industry, but I would like to share some thoughts I had as well.
Cost and logistics permitting, I would suggest purchasing all the equipment from one company. That way there aren´t communication issues between components and technical support is easier. This is by no means necessary, but could make your life easier in the long run, as you won´t be dealing with multiple providers.
A nice complementary system to a DAD detector would be a low-end mass spectrometer for confirmation and additional selectivity. It might be helpful in identifying impurities.
If you are going to do QC work, it´s also important to have in place a quality system and work towards some sort of certification so your results are considered credible.
Hi, I agree with previous comments. If it is possible you can complete your HPLC system as described above, it will be very nice. If it is not, I think you can buy first DAD detector and a Rheodyne injector, after this you can complete your HPLC system with other options (auto sampler (with variable injection volumes), oven etc).
To do the drug sample analysis, one should have high pressure gradient HPLC system with PDA detector and Fluorescent detector, auto sampler, column oven, Degasser, sample cooler.
Almost all recent HPLCs are much advanced in operation and processing. You have an isocratic system, that limits most of the applications such as related impurity analysis. At the same time you may need to have additional / optional detectors other than simple UV-Vis detector depending on the nature of your drug. You may need t explore the various new HPLC columns that are available in the market too. I would suggest you may consider getting a gradient HPLC system from any of the major brands WATERS, AGILENT, SHIMADZU. To start with a basic gradient with UV-VIs system, try with WATERS 2695 Alliance system with PDA2996 , Empower II or III software. PDA detectors are UV-Vis multi wavelength detectors (190 to 700 NM) has advantage of extracting chromatogram at any wavelength of interest, and at the same time you will have the UV-VIS spectrum of any peaks of interest. Agilent 1200 series and Shimadzu LC 20 series are also equally good options
The system suggested by Bill above is as close to a "standard" system as can be suggested without knowing your applications. Start with your drug. Does it have a UV chromophore? If not, the UV detector is almost useless. Most labs have different HPLC systems with different capabilities. If you already have a diode array system, your second system can have a much cheaper UV detector. Fluorescence ELSD and Mass spectrometric detectors are sometimes necessary. Check the literature for methods on similar molecules.