FORMULATION EVALUATIONSAssay of For

FORMULATION EVALUATIONS
Assay of Formulations
Reference Solution Preparation
100ml of stock reference solutions for each
formulation was prepared. The composition of the
reference stock solution was similar to that of the
respective formulations excluding the drug and also
they were diluted similarly as the formulations
were diluted using water.
Sterilization Studies
The injection samples were taken in glass syringe,
the membrane filter holder was attached to the
syringe. A prefilter of 1.5 micrometers was placed
in this holder, after which filters of 0.22, 0.45, 1.2
and 1.5 micrometers were placed successively and
tested whether the injection sample could pass
through these membrane or not.
Crystal Growth
10 ml of the each prepared formulations F5 and F6
were placed at refrigeration, room temperature,
37°C, 40°C and 45°C respectively for six weeks
and observed for crystal growth.
pH Changes
10 ml of the each prepared formulations F5 and F6
were kept at different temperatures/conditions such
as refrigeration, room temperature, 37°C, 40°C,
45°C and under light. At regular time intervals the
samples were examined for pH changes for six
weeks using a digital pH meter.
Clarity
10 ml of the formulations were placed at
refrigeration, room temperature, 37°C, 40°C and
45°C for six weeks and observed for colour change
or turbidity.
% Drug Content
The drug content of the formulations F5 and F6
were determined by following the same procedures
as mentioned in assay. The estimates were done at
intervals of one week upto six weeks.
Dilution study7,8,9,10
Precipitation of drug often occurs upon injecting
a formulation into body fluids. The amount of
precipitation can be correlated with the rate at which the
drug is injected. Method for determination of such
effect is dilution study.
The serial dilutions of formulations were prepared
in ratio of 20:50 to 20:500 and stored at room
temperature and examined visually for the
appearance of crystals and turbidity upto 24 hours.
Shelf Life Determination11,12,13,14
The injections stored at 37 ºC, 40ºC, 45ºC and light
were subjected to the shelf life determination
studies.
Prediction of Shelf Life
The log percentage drug retained (undecomposed)
values of the four formulations F5 and F6 stored at
37 ºC, 40 ºC and 45 ºC are given in Table 30 and
are graphically represented in Figure 3 to 6. The
results obtained of the above graphs using
Arrhenius plot shelf life of the all four formulations
were predicted.