Development and validation of a spectrophotometric method for the analysis of propranolol in a new soft dosage form "Propranozol"

At present, the issue of creating and introducing into medical practice domestically produced drugs, the quality of manufacture of which is established using objective, highly sensitive optical physical and chemical methods, becomes relevant. Objective: to develop a spectrophotometric method for analysis of propranololol in the ointment "Propranozol" made on the basis of "Tizol" gel. Materials and methods. Pharmaceutical substance propranolol, gel "Tizol", soft dosage form "Propranosol" containing 0.5% of beta-adrenoblocker in titanium-containing base were used in the study. The analysis was carried out by spectrophotometric method in the near ultraviolet region using a domestic device SF-2000. The method was validated according to State Pharmacopoeia of the Russian Federation, XIV edition, General Pharmacopeia Article 1.1.0012.15 "Validation of analytical methods". The developed method was validated according to the following metrological characteristics: specificity, linearity, reliability and precision. Statistical processing of the measurement results was performed according to the requirements of SPh RF XIV edition by methods of modern mathematical statistics (regression analysis), using a personal computer and MSOffice application package. Results. When studying propranolol absorption spectra in the ultraviolet region it was found that spectrophotometric analysis of this compound is rationally performed at a wavelength of 290 nm. The content of propranolol in the soft dosage form, found by the equation of the calibration graph, is within the range of 0.0470-0.0582 g, which corresponds to the allowable standards of deviation given in the regulatory documentation. Conclusion. During the experimental study optimal conditions were chosen and the method of spectrophotometric quantitative determination of propranololol in the ointment "Propranozol" was developed with the relative error not exceeding ± 1.60 %.

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