Abstract

L. Shiva Kumar Reddy¹*, Dr.S.L.N. Prasad Reddy², G.Srinivas Reddy³

DOI : http://dx.doi.org/10.13005/ojc/300340

A novel stability indicating reversed-phase liquid chromatographic method has been developed and validated for simultaneous estimation of Dosulepin hydrochloride and Methylcobalamin in combined pharmaceutical dosage form. An Inertsil-ODS (250mmx4.6mmx5mic) column with mobile phase containing 0.02 % Orthophosphoric acid and Methanol (400:600 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 223 nm. The retention times of Dosulepin and Methylcobalamin were found to be 2.633 min and 3.794 min, respectively. Correlation co-efficient for Dosulepin and Methylcobalamin were found to be 0.99 and 0.99, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Dosulepin and Methylcobalamin in formulations was found to be in a range of 97-103% and 97-103% respectively. Dosulepin hydrochloride and Methylcobalamin were also subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from and peak purity test results confirmed that Dosulepin and Methylcobalamin 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.

Dosulepin; Methylcobalamin; Liquid chromatography; Method validation; Forced degradation

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