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Cyclobenzaprine drug assay and cyclobenzaprine-excipient interaction study by chromatography, thermal and spectral analysis.

Rajasekhar Tulasi Baru

The present study was carried out to investigate the compatibility of Cyclobenzaprine hydrochloride, a muscle relaxant and antidepressant with different pharmaceutical excipients. The study involved storing drug-excipient blends (200 mg) with 20% added moisture in closed glass vials at 100°c for 24 hours. A LC method was developed and validated for determination of cyclobenzaprine. The mobile phase consists of potassium dihydrogen phosphate buffer (20 mM, pH 3.0): methanol with flow rate 1.2 mL/min and UV detection at 289 nm. A good linearity was obtained with concentration ranging from 5-50 µg/mL. The HPLC study showed, drug interacts with some commonly used pharmaceutical excipients. The results were fairly good in agreement with the cyclobenzaprine hydrochloride-excipient interaction analysis, obtained from DSC, FTIR and UV-DRS. The HPLC method was validated as per ICH guidelines and applied for quality control of bulk and formulation of cyclobenzaprine hydrochloride.