Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DISSOLUTION STUDY OF PANTOPRAZOLE SODIUM AND DOMPERIDONE IN CAPSULE DOSAGE FORM

Nileshkumar H. Varu* and Dr. Parula B. Patel

ABSTRACT

RP-HPLC method for dissolution study of Pantoprazole sodium and Domperidone in capsule dosage form was developed and validated. In RP-HPLC method for Pantoprazole sodium and Domperidone, chromatographic separation was carried out on Waters spherisorb®, 5μm, ODS (250 mm L × 4.6 mm Ø in size) column using mobile phase mixture comprising a Methanol:Acetonitrile (90:10 % v/v) and flow rate 1.0 ml/min at 288 nm. RP-HPLC method was developed with linearity range of 2 - 24 μg/ml and 1.5 - 18 μg/ml for Pantoprazol sodium and Domperidone respectively. The average retention times for Pantoprazole sodium and Domperidone were found to be 2.99 and 6.48 min respectively. Validation of developed method was performed according to ICH Q2 (R1) guideline. In vitro drug release studies of the sustained release capsule were conducted for a period of 24 hours by using an IP Type II (Basket) Dissolution apparatus (PLC Dissolution Rate Test Apparatus U.S.P/B.P/I.P. STD) at 37± 0.5°C temperature. The agitation speed was 100 rpm. The dissolution study was carried out in 900 ml of 0.1 N hydrochloric acid for first 2 hours, in 900 ml of 0.2 M phosphate buffer (pH 6.8) within 5 hours and then in 900 ml of 0.2 M phosphate buffer (pH 7.4) within 24 hours. Pantoprazole sodium and Domperidone sustained release capsules mean % cumulative release is 97.02 ± 1.7611 for Pantoprazole sodium within 7 hrs and 94.46 ± 1.9395 for Domperidone within 24 hrs. The result of the peak area obtained by the drug injected every hour upto 24 hrs was compared with the assay result obtained by performing the RP-HPLC method of Pantoprazole sodium and Domperidone in the mobile phase of Methanol:Acetonitrile(90:10 %v/v).

Keywords: RP-HPLC, In vitro Dissolution study, Pantoprazole sodium, Domperidone, Sustained release capsule.