Pharmaceutica Analytica Acta

Abstract

A Validated Stability–Indicating HPLC Method estimation of Clonazepam In the bulk drug and Pharmaceutical Dosage Form

Pallavi Mangesh Patil, Sagar Baliram Wankhede and Praveen Digambar Chaudhari

A rapid, accurate, linear, and sensitive RP-HPLC method has been developed and validated for estimation of Clonazepam in the bulk and Pharmaceutical Dosage Form. The chromatographic separation was performed on C18 Column (250 mm × 4.6 mm, 5 μm particle size) using a mobile phase Acetonitrile: Methanol (60:40 v/v) at flow rate of 1.0 ml/min and 30°C column temperature with the detection wavelength at 254 nm. The Clonazepam (RT 6.11 min).The linearity was performed in the concentration range of 5 to 25 μg/ml for Clonazepam R2 0.9993, Clonazepam. The percentage purity of Clonazepam was found to be 99-101%. Precision (Inertday) of the system was found to be 0.48% Clonazepam and all the method was found to be specific and found to be within the limits of the acceptance criteria. The limit of detection was 0.092 μg/ml and limit of quantification was 0.97 μg/ml. Clonazepam was found to be specific. The Proposed method has been validated for which were within the acceptance limit according to ICH guidelines. Forced degradation conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A (R2). The drug showed instability in alkaline and oxide, while it remained stable in acid conditions.