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Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC SODIUM AND DICYCLOMINE HYDROCHLORIDE IN INJECTION DOSAGE FORM

Ritukumari D. Santoki* and Dr. Parula B. Patel

ABSTRACT

RP-HPLC and UV-Spectroscopic methods for simultaneous estimation of Diclofenac sodium and Dicyclomine hydrochloride in injection dosage form was developed and validated. In UV- Spectrophotometric method, absorbance was measured at 276.80 nm for Diclofenac sodium (at 276.80 nm absorbance of Dicyclomine hydrochloride is zero) and 216.80 nm for Dicyclomine hydrochloride by absorbance correction method. Absorbance correction method was developed with linearity range of 5 - 25 μg/ml and 2 - 10 μg/ml for Diclofenac sodium and Dicyclomine hydrochloride respectively. In HPLC method for Diclofenac sodium and Dicyclomine hydrochloride, chromatographic separation was carried out on Waters spherisorb®, 5 μm, ODS (250 mm L × 4.6 mm Ø) in size using mobile phase mixture comprising a 20:20:60 (% v/v/v) of Acetonitrile: methanol: 0.05 M phosphate buffer (pH 6.5) and flow rate 1.0 ml/min at 215 nm. RP-HPLC method was developed with linearity range of 25 - 125 μg/ml and 10 - 50 μg/ml for Diclofenac sodium and Dicyclomine hydrochloride respectively. Validation of developed methods was performed according to ICH Q2 (R1) guideline.

Keywords: Analytical Method Development, Validation, RP-HPLC, UV Spectroscopy, absorbance correction method, Diclofenac sodium, Dicyclomine hydrochloride.


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