
pooja patil
M.pharma post graduate student in QA.
QA executive at J.B. chemicals and pharmaceuticals ltd. (GUJ, India)
Supervisors: Dr. Hasumati raj
Address: Surat, Gujarat
QA executive at J.B. chemicals and pharmaceuticals ltd. (GUJ, India)
Supervisors: Dr. Hasumati raj
Address: Surat, Gujarat
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Papers by pooja patil
Methods: Absorbance ratio method for the ratio of absorbance at two selected wavelengths, one which is an iso-absorbtive point and other being the λ-max of one of the two components. Atenolol and Ivabradine HCl showed an iso-absorbtive point at 286.40 nm in methanol. The second wavelength used was 276 nm which is λmax of Atenolol in methanol. So it was economic in nature. The linearity was obtained in the concentration range of 20-100 µg/ml for Atenolol and 2-10 µg/ml for Ivabradine HCl. The concentration of the drugs was determined by using ratio of absorbance at iso-absorbtive point and at the λmax of Atenolol.
Results: This method is linear for both drugs; in range 2-10 µg/ml for Ivabradine HCl and 20-100 µg/ml for Atenolol found at λmax of Atenolol 276nm (R2 = 0.9990) and at Iso-absorptive point 286.40 nm (R2 = 0.9998). % recovery for Ivabradine HCl found 100.47% and Atenolol 100.32%. And all validation parameter (Robustness, Ruggedness, Interday, Intraday) show %RSD >2%. And Limit of detection for Ivabradine HCl and Atenolol at λ1 (maximum wavelength) and λ2 (Iso-absorptive point) was found 0.309 and 0.181 respectively. % Assay for Ivabradine HCl and Atenolol found to be 100.58% and 100.13% respectively.
Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which was considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.
Methods: Absorbance ratio method for the ratio of absorbance at two selected wavelengths, one which is an iso-absorbtive point and other being the λ-max of one of the two components. Atenolol and Ivabradine HCl showed an iso-absorbtive point at 286.40 nm in methanol. The second wavelength used was 276 nm which is λmax of Atenolol in methanol. So it was economic in nature. The linearity was obtained in the concentration range of 20-100 µg/ml for Atenolol and 2-10 µg/ml for Ivabradine HCl. The concentration of the drugs was determined by using ratio of absorbance at iso-absorbtive point and at the λmax of Atenolol.
Results: This method is linear for both drugs; in range 2-10 µg/ml for Ivabradine HCl and 20-100 µg/ml for Atenolol found at λmax of Atenolol 276nm (R2 = 0.9990) and at Iso-absorptive point 286.40 nm (R2 = 0.9998). % recovery for Ivabradine HCl found 100.47% and Atenolol 100.32%. And all validation parameter (Robustness, Ruggedness, Interday, Intraday) show %RSD >2%. And Limit of detection for Ivabradine HCl and Atenolol at λ1 (maximum wavelength) and λ2 (Iso-absorptive point) was found 0.309 and 0.181 respectively. % Assay for Ivabradine HCl and Atenolol found to be 100.58% and 100.13% respectively.
Conclusions: The method was successfully applied to pharmaceutical synthetic mixture which was considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.