DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BECLOMETHASONE DIPROPIONATE AND SALBUTAMOL SULPHATE
Keywords:
High performance liquid chromatography (HPLC), Beclomethasone dipropionate, Salbutamol sulphate, Stability indicating, ValidationAbstract
Objective: To develop a validated stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of Beclomethasone dipropionate (BEC) and Salbutamol sulphate (SAL) in bulk and combined dosage form.
Methods: An isocratic, RP-HPLC method was developed using Hi Q Sil C18 (250 x 4.6 mm, 5 µm) column and 1 mM ammonium acetate buffer and methanol (15:85 v/v) as mobile phase at flow rate of 1 ml/min and detection wavelength of 230 nm.
Results: The chromatographic conditions yield good separation between drugs with retention time (RT) of 7.75±0.03 min and 2.36±0.09 min, for BEC and SAL, respectively. The method was validated with respect to linearity, precision, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 5–30 µg/ml concentrations with a correlation coefficient (r2) of 0.997 for both the drugs.
Conclusion: The developed method was found to be simple, sensitive, selective, accurate, and repeatable for simultaneous analysis of BEC and SAL and can be adopted for routine analysis of these drugs in bulk and pharmaceutical dosage form.
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