STABILITY INDICATING SIMULTANEOUS VALIDATION OF AZELAIC ACID, MINOXIDIL AND TRETINOIN WITH FORCED DEGRADATION BEHAVIOR STUDY BY RP-HPLC IN PHARMACEUTICAL DOSAGE FORM.
Akhilesh Sharma*, Anurag Mishra and Sanjay Sharma
ABSTRACT
A simple, precise, and accurate RP-HPLC method has been developed and validated for the simultaneous assay of Azelaic acid, Minoxidil and Tretinoin in topical gel. Isocratic RP-HPLC method was developed on BDS hypersil C18, (250mm×4.6mm internal diameter, 5μ particle size) using mobile phase as 0.05M Potassium Dihydrogen Phosphate (pH-4.0): Methanol (80:20v/v) at a flow rate of 1.0 mL/min and the detection was carried out at 243nm using tunable absorbance detector (Waters 486). Forced degradation study was carried out by acid degradation, base degradation, thermal degradation, oxidation of the drug. The method was validated for linearity, precision, accuracy and robustness. The method was found to be linear in the concentration range of 7.5-37.5 𝜇g/mL with correlation coefficient of 0.9995 for Azelaic acid, 25-125 𝜇g/mL with correlation coefficient of 0.9999 for Minoxidil and 0.5-2.5 𝜇g/mL with correlation coefficient of 0.9996 for Tretinoin. Degradation products produced as a result of stress studies did not interfere with the detection of Azelaic acid, Minoxidil and Tretinoin; therefore, the assay can be considered to be stability indicating.
Keywords: HPLC, Azelaic acid, Minoxidil, Tretinoin, Validation, Forced degradation.
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