DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF LOXAPINE SUCCINATE IN CAPSULE DOSAGE FORMAbstract
To develop and validate simple, selective, specific, sensitive and accurate stability indicating assay method by RP-HPLC for determination of Loxapine succinate in the capsule dosage form. Several trials are taken by changing mobile phase composition, and ratio and finally the drug was eluted on a C18 Purospher star (250 mm × 4.6 mm, 5 µm) column using mobile phase consisting of water: Methanol: Acetonitrile: TEA:: 40:10:50:1 ratio and pumped at flow rate of 1.0 ml/min using 10 µl injection volume at 254 nm. The Retention time of Loxapine succinate was found to be 10.783 ± 0.02 min. The calibration curve was linear over concentration range of 75-225 µg/ml (r2 = 0.999). The accuracy of the method was estimated by recovery studies and % recovery was in a range of 98% to 102%. Stability of Loxapine succinate was studied under different stressed condition like acid, alkali, peroxide, thermal and photolytic conditions. The drug was degraded in all conditions except thermal and photolytic conditions. The developed method was validated as per ICH guidelines.
K. A. Thakor * and T. Y. Pasha
Department of Chemistry, Parul Institute of Pharmacy and Research, Parul University, Limda, Waghodia, Vadodara, Gujarat, India.
30 August 2018
03 November 2018
09 November 2018
01 May 2019