RP-HPLC METHOD FOR DISSOLUTION TESTING OF CAPECITABINE TABLETS

Abstract

The United States Pharmacopeia (USP) monograph for capecitabine tablets uses a UV spectrophotometric method for dissolution testing, although UV detection lacks selectivity for capecitabine over co-absorbing excipients or degradation products. In the present study, an isocratic RP-HPLC technique was developed and validated for the measurement of capecitabine in dissolution samples under USP conditions. Separations were performed on a C18 column (100 × 4.6 mm, 3.5 µm) using methanol–0.1% phosphoric acid (50:50, v/v) at 1.5 mL/min; detection was at 240 nm. The approach was verified as per ICH Q2(R2). The linearity was established in the range of 5–100 µg/mL (r² = 0.999) with LOD and LOQ of 0.83 and 2.55 µg/mL, correspondingly. The recovery was 98.0%–100.1% (RSD < 2%). The stability-indicating nature of the approach was established by forced degradation studies in acid, alkali, oxidative, thermal, and photolytic environments. Capbize® 500 mg tablets released >84% of capecitabine within 30 min, which fulfilled the USP requirement (Q ≥ 80%). The approach is more selective than the compendial UV method and suited for regular quality control of capecitabine tablets.