Abstract

STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION OF CLOMIPRAMINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

*Thakkar Hiren G., Dr. Zarna Dedania and Dr. Ronak Dedania

ABSTRACT

The HPTLC performed on pre-coated silica gel 60F254 aluminum plate using mobile phase Methanol: Acetic Anhydride: Chloroform (5.5: 1.5: 3.0, v/v/v) with UV detection at 255 nm. The Calibration Curve were found to be linear in the range in in HPTLC 100-600ng/spot with Correlation Coefficient 0.999. precision Intraday precision of Clomipramine Hydrochloride was found to be 0.55-0.59% RSD and Interday precision were found to be 0.51-0.58% RSD respectively. The Limit of Detection and Limit of Quantitation were found to be 7.780ng/ml and 23.57ng/ml respectively. The %Recovery of Clomipramine Hydrochloride was found to be in range of 99.47 ± 0.20 - 101.16 ± 0.80%. The proposed method was successfully applied for the estimation of in Marketed Tablet Formulation of Clomipramine Hydrochloride was found to be 99.45 ± 0.88. Clomipramine Hydrochloride was subjected to Stability studies under Acidic, Alkaline, Oxidation, Dry Heat and Photolytic degradation conditions. Clomipramine Hydrochloride showed 17.31% degradation under acidic condition, 24.13% under alkaline condition, 28.90% under oxidation condition, 12.34% under dry heat condition and 15.90% under photolytic condition. The low values of standard deviation indicate the suitability of this method for routine analysis of Clomipramine Hydrochloride in pharmaceutical dosage forms.

Keywords: HPTLC, Clomipramine Hydrochloride, Method Validation, Stability Indicating.