PRE-FORMULATION STUDIES 43 Institute of Pharmaceutical Sciences & Research Centre, Bhagwant University, Ajmer Preformulation Studies: - 100-102 The following Preformulation studies were carried out, Identification of the drug Analytical method for satranidazole Solubility studies Loss on drying Partition coefficient Particle size determination Thin layer chromatography Drug – Excipient interaction IDENTIFICATION OF DRUG Colour : pale yellow or yellow colour Nature : Crystalline Odour : Odorless Taste : Bitter Melting point: The drug (Satranidazole) was taken into melting point capillary tube and melting point was determined by using digital auto melting point apparatus. The melting point of the drug was found to be 185-191 o C.
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PRE-FORMULATION STUDIES
43 Institute of Pharmaceutical Sciences & Research Centre, Bhagwant University, Ajmer
Preformulation Studies: - 100-102
The following Preformulation studies were carried out,
Identification of the drug
Analytical method for satranidazole
Solubility studies
Loss on drying
Partition coefficient
Particle size determination
Thin layer chromatography
Drug – Excipient interaction
IDENTIFICATION OF DRUG
Colour : pale yellow or yellow colour
Nature : Crystalline
Odour : Odorless
Taste : Bitter
Melting point:
The drug (Satranidazole) was taken into melting point capillary tube and melting point
was determined by using digital auto melting point apparatus.
The melting point of the drug was found to be 185-191 oC.
PRE-FORMULATION STUDIES
44 Institute of Pharmaceutical Sciences & Research Centre, Bhagwant University, Ajmer
IR Study7
Fig-2 Infra red spectral characteristics of Satranidazole
PRE-FORMULATION STUDIES
45 Institute of Pharmaceutical Sciences & Research Centre, Bhagwant University, Ajmer
Table 6: Infra red spectral characteristics of Satranidazole
S.No. Wave number (cm-1) Interpretation
1 1740.44 C = O Stretching
2 1533.13 Asymmetric NO2 Stretching
3 1384.64 Symmetric NO2 Stretching
4 1330.64 Asymmetric SO2 Stretching
5 1167.69 Symmetric SO2 Stretching
6 3114.47 C-H Stretching for Pyrazine
7 3014.19 C-H Asymmetric Stretching for Methyl group
8 2926.45 C-H Symmetric Stretching for Methyl group
9 2976.81 C-H Asymmetric Stretching for Methylene group
ANALYTICAL METHOD FOR SATRANIDAZOLE
UV spectrum of Satranidazole in methanol
Satranidazole can be estimated by UV Spectrophotometrically in solvent. A solution of
Satranidazole was prepared in methanol gives maximum absorbance at ٨ max of 318 nm.
Preparation of Calibration Curve
1000 µg/ml (10mg/10ml) stock solution of drug was prepared in methanol solution and
suitable dilutions were made i.e.5 µg /ml, 10 µg /ml, 15µg /ml, 20 µg /ml and 25 µg /ml
respectively. The sample was scanned at ٨max 318nm. The absorbance of samples of
different concentration at the previously measured ٨max (at 318 nm). The graph was
plotted between the absorbance and concentration. The graph obeyed the Beer-Lambert’s
law in the selected concentration range.
PRE-FORMULATION STUDIES
46 Institute of Pharmaceutical Sciences & Research Centre, Bhagwant University, Ajmer
Table 7: Calibration curve in Methanol
S.No. Conc.(µg/ml) Absorbance Absorbance after regression
1. 0 0 0
2. 5 0..173 0.150
3. 10 0.346 0.301
4. 15 0.525 0.452
5. 20 0.620 0.603
6. 25 0.790 0.754
y = 0.0323x
00.20.4
0.60.8
1
0 10 20 30Concentration (mcg/ml)
Abs
orba
nce
Fig.3 Calibration curve of Satranidazole in methanol
PRE-FORMULATION STUDIES
47 Institute of Pharmaceutical Sciences & Research Centre, Bhagwant University, Ajmer
UV spectrum of Satranidazole in phosphate buffer
1000 µg/ml (10mg/10ml) stock solution of drug was prepared in phosphate buffer
solution (pH 7.4) and suitable dilutions were made i.e.5 µg/ml, 10 µg/ml, 15 µg/ml, 20
µg/ml and 25 µg/ml respectively. The sample was scanned at ٨max 318nm. The
absorbance of samples of different concentration at the previously measured ٨max (at
318 nm). The graph was plotted between the absorbance and concentration. The graph
obeyed the Beer-Lambert’s law in the selected concentration range.
Table 8: Calibration curve of Satranidazole in pH 7.4 phosphate buffer