VALIDATED STABILITY INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL, TRAMADOL AND DICYCLOMINE IN TABLETSAbstract
A new simple stability indicating reversed-phase liquid chromatographic method has been developed and validated for simultaneous estimation of Paracetamol, Tramadol and Dicyclomine in combined pharmaceutical dosage form. An Agilent Zorbax SB C18 (250mmx4.6mm, 5microns) column with mobile phase containing ammonium acetate: acetonitrile (700:300 v/v) was used. The flow rate was maintained at 1.0 mL/min, column temperature was 30°C and effluents were monitored by using a photodiode array detector at 233 nm. The retention times of Paracetamol, Tramadol and Dicyclomine were found to be 2.331, 3.182 and 7.650 min, respectively. Correlation co-efficient for Paracetamol, Tramadol and Dicyclomine were found to be 0.99, 0.99 and 0.99 respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Paracetamol, Tramadol and Dicyclomine in formulations was found to be in a range of 98-102%, 98-102% and 98-102% respectively. Paracetamol, Tramadol and Dicyclomine dosage form is also subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved and peak purity test results confirmed that Paracetamol, Tramadol and Dicyclomine peaks were homogenous and pure in all stress samples, thus proving stability-indicating power of the method. Due to its simplicity, rapidness and high precision, this method can be applied for regular analysis.
Shivakumar Reddy L. *, Prasad Reddy S. L. N , Srinivas Reddy G. and Surender Reddy L.
Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Hyderabad, Andhra Pradesh, India
22 July, 2014
29 September, 2014
01 December, 2014
01 March, 2015