DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC AND SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESILATE AND BISOPROLOL FUMARATE IN TABLET DOSAGE FORM.
*Vaishali S. Patil, Ajay N. Talele and Sachin B. Narkhede
ABSTRACT
A simple, rapid, precise and accurate stability-indicating RP-HPLC method were developed and validated for the simultaneous determination of Amlodipine Besilate and Bisoprolol Fumarate in pharmaceutical dosage form. Method include Agilent C18 (250mm * 4.6 mm, 5μm) column and Acetonitrile: Methanol: 50 mM Potassium Dihydrogen Phosphate (25:25:50% v/v/v) as mobile phase at 1.0 ml/min flow rate. Detection was carried out at 274nm. Rt was found to be 9.275 min for Amlodipine Besilate and 4.808 min for Bisoprolol Fumarate. For stability study drugs were subjected to acid hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation. Amlodipine Besilate and Bisoprolol Fumarate both was highly susceptible to oxidative condition. Pharmaceutical dosage form was more stable than Active pharmaceutical ingredient. The linearity of the proposed method was investigated in the range of 100-500μg/ml (r2= 0.999) for Amlodipine Besilate and 100- 500μg/ml (r2= 0.999) for Bisoprolol Fumarate. The limit of detection were 4.0096μg/ml and 2.0388 μg/ml and the limit of quantification were 12.1504 μg/ml and 6.1738 μg/ml for Amlodipine Besilate and Bisoprolol Fumarate respectively.
Keywords: Amlodipine Besilate, Bisoprolol Fumarate, Stability Indicating RP-HPLC method, Forced degradation Studies, Simultaneous Equation Method.
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