e -Issn : 0976 - 3651
Print-Issn : 2229-7480

  ABSTRACT

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF RUPATADINE FUMARATE AND MONTELUKAST SODIUM IN BULK AND PHARMACEUTICAL DOSAGE FORM

The method for the simultaneous estimation of Rupatadine Fumarate (RUPA) and Montelukast Sodium (MONT) in tablet dosage form has been developed, based on simultaneous equation method at two selected wavelengths 213.0 nm and 283.0 nm respectively in Methanol, and also multicomponent method at two selected wavelengths 213.0 nm and 243.0 nm. The linearity ranges for RUPA and MONT was 5–30µg/ml. The percentage drug estimated in marketed preparation, in simultaneous equation method was 100.12% and 99.83% for RUPA and MONT respectively and in multicomponent method was 100.09% and 99.99% for RUPA and MONT respectively. The method was validated for various parameters as per ICH guidelines and USP requirements. The accuracy of the methods was assessed by recovery studies and was found to be 100.02–100.08% for RUPA and 99.83–100.06% for MONT in simultaneous equation method and 100.0–100.16% for RUPA and 99.83–100.03 for MONT in multicomponent method. These methods are simple, accurate, sensitive, cost effective and specific.

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