QUANTIFICATION OF SSRR IMPURITY OF ORLISTAT IN ORLISTAT CAPSULES BY NORMAL PHASE HPLC UV DETECTOR
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 4
Abstract
A simple and efficient NP-HPLC UVD method was developed and validated for the quantitative determination of Orlistat SSRR Impurity in Orlistat dosage forms. An isocratic separation was achieved by using a Chiral Pack IA, 250 mm × 4.6 mm, 5 µm particle size column with a flow rate of 1.0 ml/min and using a UV detector at 205 nm. The mobile phase consists of n-Hexane and Isopropyl alcohol (70:30, v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and SSRR Isomer of Orlistat in an overall analytical run time of approximately 45 min with the parent compound Orlistat eluting at approximately at 5 min. The method was linear over the concentration range of 3.1 - 40 µg/ml with a limit of detection and limit of quantification 1.0 µg/ml and 3.1µg/ml respectively. The method has been the requisite accuracy, selectivity, sensitivity and precision. Degradation products resulting from the stress studies did not interfere with the detection of Orlistat and SSRR Impurity and the test method is thus stability-indicating.
Authors and Affiliations
Ashok Palakurthi , Vinta Bhanu Reddy, Sivaranjani Thiyaharajan
Keywords
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