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Dissolution study and method validation of alprazolam by high performance liquid chromatography method in pharmaceutical dosage form

Author Affiliations

  • 1Central research Laboratory, D.G. Ruparel College, Matunga, Mumbai-400016, India
  • 2Central research Laboratory, D.G. Ruparel College, Matunga, Mumbai-400016, India

Res. J. Recent Sci., Volume 6, Issue (3), Pages 13-18, March,2 (2017)

Abstract

Dissolution study was carried for alprazolam tablets containing 0.25 mg of active pharmaceutical ingredient. From the solubility study, conditions selected for paddle was 100 rpm, using 500 ml potassium dihydrogen phosphate of pH 6.8 at temperature as 37°C. These conditions are useful for % release of alprazolam coated 0.25 mg. The validation of dissolution of alprazolam was achieved on symmetyshield RP8 (150 x 3.9 mm i.d, 5 µ.) column was most suitable for dissolution study with mixture of (60:40 % v/v) of buffer and acetonitrile as mobile phase. A 0.1 % orthophosphoric acid was used as a buffer and to tri-ethylamine was used to adjust the pH 3.0 of buffer. The potassium dihydrogen phosphate of pH 6.8 was used as a diluent. The detector wavelength was set at 225 nm. Flow rate was adjusted at 0.8 ml/min. The validation of method was performed as per ICH guidelines. The linearity was found between 50- 150% with coefficient of co-relation was 0.996. The % RSD of precision was 0.66%.

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