DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF ATENOLOL AND HYDROCHLORTHIAZIDE IN COMBINED SOLID DOSAGE FORM
Keywords:
Atenolol, Hydrochlorothiazide, Reverse phase HPLC, Isocratic elution, Validation, Stability indicatingAbstract
Objective: To develop a simple, selective and rapid stability indicating reversed phase high performance liquid chromatographic (HPLC) method for the analysis of Atenolol and hydrochlorothiazide in combined in combined pharmaceutical dosage form as per ICH guidelines.
Methods: The separation was achieved from C18 column at 25oc with a mobile phase consisting of methanol: phosphate buffer in the ratio of 70:30 v/v with a flow rate of 0.5 ml/min (UV detection at 226 nm) and the retention time was about 2.3 min for Atenolol and 2.9 for hydrochlorothiazide. This method was selective to Atenolol and hydrochlorothiazide and also describes the analysis of degraded products of Atenolol and hydrochlorothiazide.
Results: ATN and HCZ were found to be linear in the concentration range of 20 – 100 µg/ml and 10 – 50 µg/ml respectively. Amount of ATN and HCZ were found in the range from 99.14 – 101.56% and 95.44 – 99.80% respectively. The amounts of degradation products for ATN were found to be 9.45% (in acidic condition), 34.9% (in basic condition), 0.15% (in oxidized condition), 4.55% (in thermal condition), 2.65% (in UV degradation at 254 nm) and 2.4% (in UV degradation at 366 nm). The amounts of degradation products for HCTZ were found to be 0.5% (in acidic condition), 8.0% (in basic condition), 8.1% (in thermal condition), 5.5% (in UV degradation at 254 nm) and 4.0% (in UV degradation at 366 nm).
Conclusion: The developed stability indicating assay method was found to be simple, accurate, sensitive, précised, specific and rapid. This method can be applied for routine quantitative analysis of Atenolol and hydrochlorothiazide in bulk and pharmaceutical formulation like tablets. This method was also capable to separate the degradation product of both drugs. Hence, it can be used to check the quality of product after different storage conditions and also in stress degradation study.
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