1Department of Quality Assurance Techniques, Bharati Vidyapeeth University, Poona College of Pharmacy, Erandwane, Pune-411038, India
2Department of Pharmaceutical Chemistry, Bharati Vidyapeeth University, Poona College of Pharmacy, Erandwane, Pune-411038, India
In the present study a rapid specific economical HPTLC method has been developed for determination of Metoprolol tartrate in bulk and pharmaceutical dosage form. Chromatographic separation was achieved on aluminium plates precoated with silica gel 60 F254 aluminium plates with mobile phase of chloroform: methanol: ammonia 9: 1: 0.05 (v/v/v). Detection was performed densitometrically at 225 nm using Camag TLC scanner. The Rfof Metoprolol tartrate found to be 0.26±0.02 and linearity was found in the concentration range of 200–1200 ng/spot with correlation coefficient (R2) of 0.998. The method was validated as per ICH guidelines for precision, recovery and robustness. Metoprolol was subjected to acid and alkaline hydrolysis, oxidation, photochemical and thermal degradation as per ICH guidelines. Method developed was stability indicating. Statistical analysis proves that the method is suitable for the analysis of Metoprolol tartrate in bulk drug and in pharmaceutical formulations without any interference from the excipients.
Metoprolol tartrate, Thin layer chromatography, Stability indicating, Degradation, Validation, ICH guidelines