A Validated StabilityÂ–Indicating HPLC Method estimation of Clonazepam In the bulk drug and Pharmaceutical Dosage Form
- *Corresponding Author:
- Pallavi Mangesh Patil
P.E.Society’s Modern College of Pharmacy
Yamunanagar, Nigdi, Pune-411044, India
Tel: +91 09823720695
E-mail: [email protected], [email protected]
Received Date: December 12, 2014; Accepted Date: January 27, 2015; Published Date: February 02, 2015
Citation: Patil PM, Wankhede SB, Chaudhari PD (2015) A Validated Stability–Indicating HPLC Method estimation of ClonazepamIn the bulk drug and Pharmaceutical Dosage Form. Pharm Anal Acta 6:332. doi: 10.4172/2153-2435.1000332
Copyright: © 2015 Patil PM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.