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Separation Of Atorvastatin Related Substance API_USP Method
Application ID :
AP_1172
Analytes
- Atorvastatin Related Compound-A, Atorvastatin Related Compound-B, Atorvastatin, Atorvastatin Related Compound-C, Unknown Impurity-1, Unknown Impurity-2, Unknown Impurity-3, Unknown Impurity-4, Unknown Impurity-5, Unknown Impurity-6
Conditions
Column : zodiac phenyl column
Column Size : 250mmx4.6mm, 5µm
Mobile Phase :
Buffer: 2.84g Ammonium formate & 0.35g Ammonium acetate & dissolve in 950ml H2O adjust pH 5.0 with 20% HCOOH & dilute with water to 1L M.P.A: Acetonitrile:
Buffer (33:67) M.P.B: Acetonitrile M.P.C: Stabilizer-free Tetrahydrofuran
Flow Rate : 1.1 ml/min
Buffer Details : Separating atorvastatin-related substances using a Zodiac Phenyl column involves a specific approach in high-performance liquid chromatography (HPLC). Developing an HPLC method using a Zodiac Phenyl column for separating atorvastatin-related substances involves optimizing the mobile phase composition, gradient elution, and detection conditions to achieve accurate and reproducible results. Method development and validation are crucial steps to ensure the method is suitable for routine analysis in pharmaceutical quality control, adhering to USP guidelines and regulatory requirements.
Detector : UV 254 nmn
Column Temperature : 40°C
Sample Temperature : 4°C
Injection Volume : 15μι
Diluent/Sample Solvent : Acetonitrile:THF: Buffer (60:5:35)
Description
Separating atorvastatin-related substances using a Zodiac Phenyl column involves a specific approach in high-performance liquid chromatography (HPLC). Developing an HPLC method using a Zodiac Phenyl column for separating atorvastatin-related substances involves optimizing the mobile phase composition, gradient elution, and detection conditions to achieve accurate and reproducible results. Method development and validation are crucial steps to ensure the method is suitable for routine analysis in pharmaceutical quality control, adhering to USP guidelines and regulatory requirements.
