Development and Validation of Stability Indic...

Development and Validation of Stability Indicating Dissolution Method for Zopiclone in Pharmaceutical Dosage Form by HPLC

Author Name : Jayashri Patil, Dr. Neha Tiwari, Dr. Pragnesh Patani, Sandeep Patil

ABSTRACT

 Zopiclone belongs to a class of medicines commonly called Z-drugs. It is a novel hypnotic agent used in the treatment of insomnia. Its mechanism of action is based on modulating benzodiazepine receptors.

A simple, rapid, economical, precise and accurate stability indicating dissolution method for Zopiclone in pharmaceutical dosage form by HPLC has been developed.

The dissolution test developed and validated for Zopiclone tablets is considered satisfactory. The most discriminating conditions for dissolution testing of Zopiclone tablets (i.e., 0.1 M Hydrochloric acid dissolution medium, paddle apparatus, stirring speed of 50 rpm, and sample collection time point of 30 minutes) appear to be the best condition. The validation shows that the dissolution test is appropriate for quantification of Zopiclone in tablet pharmaceutical dosage form.

A reverse phase high performance liquid chromatographic method was developed for the Dissolution of Zopiclone in Pharmaceutical Dosage Form. The separation was achieved by Hypersil BDS, C18 (250mm x 4.6 mm x 5 µm), column at ambient temperature by using a mobile phase –Buffer solution: Methanol (45:55 v/v), at a flow rate of 1.0ml/min and UV detection was carried out at 304nm.

Retention time values of Zopiclone were found to be 4.4 minutes respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Zopiclone 4.15-12.45 μg/ml. Developed method was found to be accurate, precise and rapid for Dissolution of Zopiclone in pharmaceutical dosage form by HPLC method.

Keywords:  Stability indicating dissolution method by HPLC, Validation