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Preformulation Studies Experiment no. 1

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Demonstrated experiment
Fundamental Preformulation Studies
organoleptic properties
melting point determination
capillary method
lambda max. determination
maximum wavelength
calibration curve
regression coefficient
Straight line equation
solubility determination
shake flask method
UV spectroscopy
percentage purity test
graph between concentration & Absorbance

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Preformulation Studies Experiment no. 1

  1. 1. Aim: To demonstrate the fundamental pre- formulation study for prepared granules. Subject: Formulative Pharmacy BP-506 P By: Ms. Uditi Handa (Asst. Prof.) M.Pharma (Ph.D) GGSCOP, Yamunanagar
  2. 2. References • Handa, U.; Saroha, K. “Research and development of diazepam solid dispersion powder using natural polymers”, International Journal of Applied Pharmaceutics, volume 10, 2018, 220-225. • http//:www.arcjournals.org
  3. 3. Objectives: • Requirements: sample, weighing balance, capillary tube, melting point apparatus, thermometer, butter paper, volumetric flask (100ml, 10ml), pipette, UV- spectrometer. • Procedures: as per objectives • Results: as per objectives a. To study organoleptic properties, b. Melting point by capillary tube method, c. Identification test by Ʌmax., d. Calibration curve, e. Solubility determination,
  4. 4. a) To study organoleptic properties • Procedure: : Taste, odour & colour of the drug was determined. DRUG TEST OBSERVATION Diazepam (DZM) Colour White Odour Odourless Taste Slightly bitter taste
  5. 5. b) To study Melting point by capillary tube method. • Procedure: Melting point of drug was analysed by capillary method using melting point apparatus. METHOD USED DEMONSTTRATED EXPERIMENTAL VALUE (°C) LITERATURE VALUE (°C) Capillary method 131 131-135 Result: Observed melting point of obtained sample is approx. near to reported data which confirm the authenticity of obtained sample.
  6. 6. c) To study Identification test by Ʌmax. • Procedure: Ʌmax. Scanning helps in identifying the drug purity. The scanned graph was according to reported literature and hence confirmed that the obtained drug sample was Diazepam. 10mg Diazepam was accurately weighted and dissolved in 100 ml of Methanol to produce a solution 0.1 mg/ml. Ʌmax. DEMOSTRATED EXPERIMENTAL VALUE (nm) LITERATURE VALUE (nm) Diazepam 238 245 (methanol solution) Result: Spectrum of Diazepam was obtained in methanol solution, observed wavelength maxima was 238 nm and the %purity was found to be 97.14%. % Purity = Absorbance of Sample X 100 Absorbance of Std. Value % Purity = 238 nm X 100 245 nm % Purity = 97.14 %
  7. 7. d) To study the Calibration curve • Procedure: Preparation of standard curve: 1. 10mg Diazepam was accurately weighted and dissolved in 100 ml of Methanol to produce a solution 0.1 mg/ml. 2. 20ml of the solution was transferred in a volumetric flask and volume was made up to 100ml with distilled water. 3. 1, 2, 3, 4, 5, 6, 7, 8, 9 & 10 ml of this solution was taken in 10ml volumetric flasks and distilled water was added to adjust the volume up to the mark to prepare standard solutions. 4. These serial dilutions were carried out to get different Diazepam concentrations. 5. Standard solutions were then analysed by UV spectrophotometer at 238 nm and absorbance was noted. 6. Then the absorbance values were plotted against drug concentration and standard curve of Diazepam was produced.
  8. 8. Concentration (µg/ml) Absorbance (nm) 1 0.21 2 0.384 3 0.522 4 0.644 5 0.776 6 0.905 7 1.051 8 1.179 9 1.244 10 1.418 R² = 0.9967 y = 0.130x + 0.115 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 0 2 4 6 8 10 12 Absorbance concentration (µg/ml) Standard curve of Diazepam in Methanol DZM Linear (DZM) Result: The calibration curve of DZM was prepared in methanol solution at 238 nm and the absorbance values at different concentrations of DZM in methanol soln are shown in table and graphically represented in figure. Values of R2 (regression coefficient) was found to be 0.996.
  9. 9. e) To study the Solubility determination by shake flask method through UV-spectrometer. • Procedure: 1. The solubility of diazepam was determined in different solvents. 2. Granules in excess quantity were placed in flask’s containing 10 ml of each solvent. 3. The samples were placed in an incubator shaker at 37°c & 50 rpm for 24 hrs. 4. The solutions were analysed by UV-spectrophotometer. 5. By using straight line equation calculate the concentration by obtained absorbance. SOLVENTS SOLUBILITY Water Slightly soluble Chloroform Soluble Methanol Soluble Calculations: for water, Y= 0.130 x + 0.115 0.374 – 0.115 = 0.130 x X = 0.259/0.130 = 0.001 µg/ml Result: Very high solubility of Diazepam was observed in methanol as the concentration was found ……………… SOLVENTS CONCENTRATION (µg / ml) Absorbance (nm) Water 0.001 0.374 Chloroform 0.592 Methanol 0.845
  10. 10. Thank You

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