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PH Analysis Def Scope

Analysis scope

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100% found this document useful (1 vote)
45 views3 pages

PH Analysis Def Scope

Analysis scope

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ansarkhan17347
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Unit I Pharmaceutical Analysis Definition and Scope

1! .
Pharmaceutical Analysis :

Pharmaceutical analysis may be defined as the


application of analytical procedures used to
determine the purity, safety and quality of drugs
and chemicals. The term "Pharmaceutical
Analysis" is otherwise called Quantitative
pharmaceutical chemistry. Pharmaceutical analysis
includes both qualitative and quantitative analysis
of Drugs and Pharmaceutical substances starts
from bulk drugs (starting material) to the finished
dosage forms. In modern practice of medicine, the
analytical methods are used in the analysis of
chemical constituents found in the human body
whose altered concentrations during disease states
serve as diagnostic aids and also used to analyse the medicinal agents and their metabolites found in
biological system.

Pharmaceutical analysis is a branch of practical chemistry that involves a series of process for
identification, determination, quantification and purification of a substance, separation of the
components of a solution or mixture, or determination of structure of chemical compounds.The
substance may be a single compound or a mixture of compounds and it may be in any of the dosage
form. The substance used as pharmaceuticals are animals, plants, micro organisms, minerals and
various synthetic products.

The sample to be analysed is called as analyte and on the basis of size of sample, they can be
classified as macro(0.1 g or more), semi micro (0.01 g to 0.1 g), micro(0.001 g to 0.01 g), sub micro
(0.0001 g to 0.001 g), ultramicro (below 10-4 g), trace analysis(100 to 10000 ppm). Among all, the
semi micro analysis is widely used.

In modern practice of pharmacy it is important that Pharmacists have more than an appreciation
of quantitative analytical methodology. The term Quality as applied to a drug product has been
defined as the sum of all factors which contribute directly or indirectly to the safety, effectiveness
and reliability of the product. These properties are built into drug products through research and
during the manufacturing process by procedures collectively referred to as "Quality Control".
Quality control guarantees within reasonable limits that a drug product :
1. Is free from impurities
2. Is physically and chemically stable
3. contains the amount of active ingredient(s) as stated on the label
4. provides optimal release of active ingredient(s) when the product is administered.

TYPES OF ANALYSIS
There are main two types of chemical analysis.
1. Qualitative (identification)
2. Quantitative (estimation)

1. Qualitative analysis is performed to establish composition of natural/synthetic substances.


These tests are performed to indicate whether the substance or compound is present in the sample
Unit I Pharmaceutical Analysis Definition and Scope
2! .
or not. Various qualitative tests are detection of evolved gas, formation of precipitates, limit tests,
colour change reactions, melting point and boiling point test etc.

2. Quantitative analytical techniques are mainly used to quantify any compound or substance in
the sample. These techniques are based in (a) the quantitative performance of suitable chemical
reaction and either measuring the amount of reagent added to complete the reaction or measuring
the amount of reaction product obtained, (b) the characteristic movement of a substance through a
defined medium under controlled conditions, (c) electrical measurement, (d) measurement of some
spectroscopic properties of the compound.

SCOPE OF PHARMACEUTICAL ANALYSIS

1.Chemical methods
a)Titrimetric or volumetric method
It involves reaction of substance to be determined with an appropriate reagent as a standard
solution, and volume of solution required to complete the reaction is determined. Volumetric
methods require simple and less apparatus and they are susceptible of high accuracy.
Various types of titrimetric methods are:
i)Acid-base titrations (neutralization reactions)
ii)Complexometric titrations
iii)Precipitation titrations
iv)Oxidation reduction titrations
v)Non aqueous titrations

b)Gravimetric methods
In gravimetric analysis, a substance to be determined is converted into an insoluble precipitate in
the purest form, which is then collected and weighed. It is the time consuming process.
In electrogravimetry, electrolysis of the sample is carried out on the electrodes is weighed after
drying.
Thermogravimetry (TG) records the change in weight, differential thermal analysis (DTA) records
the difference in temperature between test substance and an inert reference material, differential
scanning calorimetry (DSC) records the energy needed to establish a zero temperature difference
between a test substance and reference material.

c)Gasometric analysis
Gasometry involves measurement of the volume of gas evolved or absorbed in a chemical reaction.
Some of the gases which are analysed by Gasometry are CO2 , N2O, cyclopropane, amyl nitrate,
ethylene, N2, helium etc.

2.Electrical methods
Electrical methods of analysis involve the measurement of electric current, voltage or resistance in
relation to the concentration of some species in the solution.
Electrical methods of analysis include:
(a)Potentiometry
(b)Conductometry
(c)Polarography
(d)Voltametry
(e)Amperometry

Potentiometry measures electrical potential of an electrode in equilibrium with an ion to be


determined. Conductometry measures electrical conductivity of an electrode with a reference
Unit I Pharmaceutical Analysis Definition and Scope
3! .
electrode while Polarography, Voltametry and Amperometry measures electrical current at a
micro-electrode.

3.Instrumental methods of analysis


Instrumental method involves measurement of some physical properties of the compound or a
substance. These methods are employed for determination of minor or trace concentration of
element in the sample.
Instrumental methods are preferred due to their selectivity, high speed, accuracy and simplicity of
analysis. Any change in the properties of the system are detected by measurement of absorbance,
specific rotation, refractive index, migration difference, charge to mass ratio etc.
Spectroscopic methods of analysis depend upon measurement of the amount of radiant energy of a
particular wavelength emitted by the sample.
Methods which include absorption of radiation are ultra violet, visible, infra red, atomic
absorption, nuclear magnetic resonance spectroscopy etc.
Emission methods involve heating or electrical treatment of the sample so that the atoms are raised
to the excited state to emit the energy and the intensity of this energy is measured. Emission
methods include emission spectroscopy, flame photometry, flourimetry etc.
Chromatographic techniques and electrophoretic methods are separation methods for the mixture
of compounds, but also applied for identification of compounds of mixtures. Various
chromatographic techniques are GC, HPLC, TLC, HPTLC, PC etc.
Mass spectrometry involves vaporisation of material using a high vacuum and the vapour is
bombarded by a high energy electron beam. Vapour molecules undergo fragmentation to produce
ions of varying size. These ions are differentiated by accelerating them in electrical field and then
deflecting them in a magnetic field. Each kind of ion gives a peak in the mass spectrum.

4.Biological and microbiological methods


Biological methods are used when potency of a drug or its derivative can not be properly
determined by any physical or chemical methods. They are called bio-assays.

Microbiological methods are used to observe potency of antibiotic or anti- microbial agents. In
antimicrobial assay, inhibition of growth of bacteria of the sample is compared with that of the
standard antibiotic. These methods include cup plate method and turbidimetric analysis.

APPLICATIONS
Manufacturing industries require both qualitative and quantitative analysis to ensure that their
raw materials meet certain specifications, and to check the quality of final product. Raw materials
are to be checked to ensure that the essential components are present within the predetermined
range of composition and there are not any unusual substances present which might upset the
manufacturing process or it may appear as a harmful impurity in the final product.
In the development of new products which contains mixtures other then the pure material, it is
necessary to ascertain composition of mixture which shows the optimum characteristics for which
the material has been developed.
Geographical surveys require analysis to determine the composition of soil sample and numerous
rock samples collected from the field.
Most of the industrial processes give rise to pollutants which may cause health related problems.
So quantitative analysis of air, water and soil sample should be carried out to determine the level
of pollution and to establish the safe limits for pollutants.

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