PRE FORMULATION STUDY:
Pre formulation testing was an investigation of physical and chemical properties of a drug substance alone and when combined with excipients. It was the first step in the rational development of dosage forms. Class: -Pre formulation study can divide into two subclasses: API characterization, Compatibility study
Active pharmaceutical ingredient (API) characterization:-
Organoleptic evaluation:-These are preliminary characteristics of any substance which is useful in identification of specific material. Following physical properties of API were studied.
a) Color
b) Odour
c) Taste
Physical Appearance The appearance of the API was done by visual observation
Solubility Studies Solubility profiles of Atorvastatin were done by solubility equilibrium method. It is done by stirring an excess of drug in the solvents water, methanol, ethanol isopropyl alcohol for a prolonged period until equilibrium is reached. It is also done in various concentrations of pH buffers.
Bulk density: …show more content…
The following analytical method is reported for the estimation of Atorvastatin.
1. UV Spectroscopy In the present investigation UV Spectrophotometer method was used for the estimation of Atorvastatin.
Construction of calibration curve for Atorvastatin.
Preparation of stock solution:
Aqueous solutions of phosphate buffer of pH 6.8 were prepared as per USP25. Standard drug solution was prepared (1mg/ml) in Phosphate Buffer 6.8. The λmax was determined in respective solvent and found to be 272nm.
Drug (100mg) was dissolved in10ml of Phosphate Buffer6.8 and the total volume was brought to 100 ml with Phosphate Buffer 6.8 to obtain stock solution .Stock solution was further diluted to obtain 5-30 μg/ml with Phosphate Buffer6.8. Standard solutions of Atorvastatin (10μg/ml) in Phosphate buffer 6.8 were scanned in the 200-400 nm range to determine the maximum absorbance
Pre formulation testing was an investigation of physical and chemical properties of a drug substance alone and when combined with excipients. It was the first step in the rational development of dosage forms. Class: -Pre formulation study can divide into two subclasses: API characterization, Compatibility study
Active pharmaceutical ingredient (API) characterization:-
Organoleptic evaluation:-These are preliminary characteristics of any substance which is useful in identification of specific material. Following physical properties of API were studied.
a) Color
b) Odour
c) Taste
Physical Appearance The appearance of the API was done by visual observation
Solubility Studies Solubility profiles of Atorvastatin were done by solubility equilibrium method. It is done by stirring an excess of drug in the solvents water, methanol, ethanol isopropyl alcohol for a prolonged period until equilibrium is reached. It is also done in various concentrations of pH buffers.
Bulk density: …show more content…
The following analytical method is reported for the estimation of Atorvastatin.
1. UV Spectroscopy In the present investigation UV Spectrophotometer method was used for the estimation of Atorvastatin.
Construction of calibration curve for Atorvastatin.
Preparation of stock solution:
Aqueous solutions of phosphate buffer of pH 6.8 were prepared as per USP25. Standard drug solution was prepared (1mg/ml) in Phosphate Buffer 6.8. The λmax was determined in respective solvent and found to be 272nm.
Drug (100mg) was dissolved in10ml of Phosphate Buffer6.8 and the total volume was brought to 100 ml with Phosphate Buffer 6.8 to obtain stock solution .Stock solution was further diluted to obtain 5-30 μg/ml with Phosphate Buffer6.8. Standard solutions of Atorvastatin (10μg/ml) in Phosphate buffer 6.8 were scanned in the 200-400 nm range to determine the maximum absorbance