García PCM, Montes de Oca PY, Martínez EV

Language: Spanish
References: 6
Page: 245-253
PDF size: 173.03 Kb.

ABSTRACT

Introduction: the 1% cyclopentolate eye drops is indicated to measure the refractive errors, to cause cycloplexy in diagnostic procedures and also preoperative and postoperative midriasis in treating uveitis and in inflammatory conditions of the iris.
Objective: to evaluate the performance of a high performance liquid chromatography applicable to the quality control and the study of the eye drops stability.
Methods: with the purpose of quantifying the active ingredient in the finished product, the method described in the US Pharmacopea (USP 32,2009) was used. The shelf life study was conducted for 24 months at controlled 15-25 ºC temperature whereas the study of accelerated stability at 40 ± 2 ºC and 75 ± 5% relative humidity lasted 6 months.
Results: the achieved results in the evaluation of the performance of the analytical method were within the set limits. The results for the shelf life stability after 24 months yielded that the product keeps the quality parameters during this time and in the accelerated stability study, there was no sign of significant degradation.
Conclusions: the evaluation of the performance of the analytical method based on high performance liquid chromatography showed its reliability. The expiry date was set at 2 years under the stated conditions.

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