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Voltammetric determination of pilocarpine hydrochloride in ophthalmic solutions
https://doi.org/10.26896/1028-6861-2022-88-4-21-26
Abstract
An express method for the determination of pilocarpine hydrochloride (PHC) in ophthalmic solutions based on titration of the analyte with photogenerated iodine obtained by irradiation of potassium iodide in the presence of a mixture of sensitizers (sodium eosinate:fluorescein:auramine in a molar ratio of 1:1:1) at pH 5.6 has been developed. The titrant content in the cell was controlled by the voltammetric method (amperometric titration with two polarized electrodes): during the PHC titration a decrease in the current strength in the circuit of the amperometric installation was observed. Stabilization of the current in the circuit of the amperometric installation indicated the completeness of the reaction, and, thus provided the possibility of estimation of the PHC content in a dosage form. The measured generation time required to replenish the loss of titrant upon further irradiation of the solution was also used to calculate the PHC content in the preparation. Testing of the developed technique was carried out on an ophthalmic drug «Pilocarpine, eye drops 1%». Introduction of more than 20.0 g of boric acid used as a preservative agent into the cell resulted in a slight underestimation of the PHC content. The determined PHC content in the sample of series 60918 is 0.93 – 0.94% (measured by generation time) is lower than the tolerance interval set by order of the Ministry of Health of the Russian Federation No. 751n, October 26, 2015 (0.95 – 1.05%). The PHC content in other samples falls within the recommended range, which indicates that the drug quality complies with GMP standards. A linear dependence of the analytical signal on the PHC concentration is observed in the range of 15 – 500 μg. The calculated detection and quantitation limits are 5.6 and 18.6 μg, respectively. The developed photochemical method for PHC determination in the drug «Pilocarpine, eye drops 1%» meets the requirements set forth in the manual for the validation of bioanalytical methods. The method is easy to use and does not require expensive equipment.
About the Authors
E. V. Turusova
I. N. Ulyanov Chuvash State University
Russian Federation
Russian Federation
428015, Cheboksary, Moskovsky prosp., 15
O. E. Nasakin
I. N. Ulyanov Chuvash State University
Russian Federation
Russian Federation
428015, Cheboksary, Moskovsky prosp., 15
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Review
For citations:
Turusova E.V., Nasakin O.E. Voltammetric determination of pilocarpine hydrochloride in ophthalmic solutions. Industrial laboratory. Diagnostics of materials. 2022;88(4):21-26. (In Russ.) https://doi.org/10.26896/1028-6861-2022-88-4-21-26
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