Answer / sushant

1.HPLC method development start with literature servey to
get rough idea abt development
2.then find out functionallity, molecular structure,
Polarity of particular API or molecule. from which we can
decide method development phase RPC or NPC.
3.Find out Solubility, Max UV absorbace so that we be
assure about respective diluent & wavelegh for method
development.
if we will not get UV absorbace then there is dervatisation
method.
4.Mostly many oragnic drug molecules are polar or mid polar
so we usually go for RPC.
5.satrt with mobile phase composition Use water & MEthanol
or ACN according to sollubillity in 50:50 ratio.
6.Select Column -start with C-18 column make HYpersil or
Inertsil(3 microne x 4.6 ID )10-15 cm
7. feed other parameter like wavelength,ambient Temp,
1ml/min Flow rate
8.About sample preparation for assay preparation use conc
in between 100-500 ppm as per peak response.
9.If there are more than 10 molecule in particular API go
for gardient method for better resolution & short run time
while developing any method always follow ICH parameter abt
Tailing factor, Capacity factor, Assymetry, thereotical
plates.Change MP composition ,Column.
Once you get better result then for sharpness or to save
time adjust flowrate & increase Temp.
10.If our desired peak isnot retain on water /ACN/Methanol
composition MP then go for Buffer. Phosphate buffer is
widly use buffer for its PKa value,easily Available, gives
more Hydrophillic effect, stable or non degradable for 2-3
days.
...............Before starting any method development on
HPLC Flush the system with water, check pressure, saturate
column with MP,check callibration status, lamp Hours.
Always keep data about whatever trials you have done during
method development.
Method Development is very challenging task so always be
logical before any changes in any parameter.

Mostly For HPLC method Development 10 gm sample is enough
but for overall development max 100 gm sample is sufficient.
Its a tentative quantity.

After method development method validation must be done.

Answer / kizar ahamed

Method development starts with solubility of the
compound,if itis soluble in water v can try with reverse
phase if is is not v should use normal phase
chromatography.

2)selection of wavelength

3) column selection

4)Gradient setting(Always develope the method by using
gradient than isocratic)

Answer / shantaram naik

depending upon response of peak prepare sample
concentration but ideally it is 10 ppm

IS THERE ANYWHERE MENTION THAT THE RE PROCESS BATCH REQUIRE TO KEPT STABILITY STYDY

2 Answers   Nakoda Chemicals,

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which chromatographic technique is used for softening hard water?

1 Answers   Laurus,

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My question about gas chromatography sulfur chemiluminsecence detector. I test unknown sample gas by GC-SCD (calibrated ) and the result of *H2S is 279 PPM , *but when I test the same sample with the GC-TCD (calibrated ) the value of *H2S is 2500 PPM . I'd like to inform you that both GCs are calibrated and have very good operation conditions with stable parameters . the question is if the sample gas with higher H2S over detection limits of SCD detector (1000 ppm). why the result it 279 ppm Best regards

0 Answers  

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in which situation ion pair require to use?

0 Answers  

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why you require QA approval & what is its importance?

2 Answers  

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AT WHAT CONDITIONS WILL YOU ANALYSE A SAMPLE,WHICH ARE PRESERVED AT OTHER THAN THE AMBIENT CONDITIONS?(ie COLD STORAGE SAMPLES BELOW 20* CENTIGRADE?

0 Answers  

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in uv visible spectroscopy calibration why we are using potasium dichromate and tolune

4 Answers   Reddy Labs,

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what is the defination of accuracy & presicion?

8 Answers   Amneal Pharmaceuticals, GSK,

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what is %labelled amount in content uniformity of dosage unit and its calculation?

0 Answers   Zydus Cadila,

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What is post run in hplc?

1 Answers   Cipla,

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what is the use of tap density apparatus? why we calculate it? what is the difference between the bulk density and tap density?

1 Answers   Alchemist, Alembic, Apex,

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which functional group we can detect in IR?

3 Answers  

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