Abstract
A simple gradient Ultra Performance liquid chromatographic method (UPLC) was developed for determination of lopinavir and ritonavir from its related impurities and assay for the first time. This method involves the use of a C18 (Acquity UPLC BEH C18, 50 × 2.1 mm, 1.7 µm) column thermostated at 30 oC using triethylamine (pH 2.2): 0.1% H3PO4 in acetonitrile and methanol (85:15) as mobile phase in gradient elution mode. A Photo Diode Array (PDA) detector set at 215 nm was used for detection with flow rate 0.4 mL/min. This method was validated over the range of limit of quantitation (LOQ) to 50 to 150% of impurity specification limit and of working concentration for assay. The developed method was validated for linearity, range, precision, accuracy and specificity. This method was successfully applied for content determination of lopinavir and ritonavir in pharmaceutical formulations. This method can be conveniently used in quality control laboratory for routine analysis for assay and related substances as well as for evaluation of stability samples of bulk drugs and pharmaceutical formulations.
Highlights
Lopinavir is an anti-Human immunodeficiency virus (HIV) drug which belongs to the class of drugs known as protease inhibitors (PIs) (Raffanti, Haas, 2001)
Lopinavir was formulated with another protease inhibitor, ritonavir
Like several other HIV protease inhibitors, its blood levels are greatly increased by low doses of ritonavir, a potent inhibitor of cytochrome P450 3A4 (Sham et al, 1998; Kumar et al, 1999) and lopinavir is co-administered with sub-therapeutic doses of ritonavir by oral administration
Summary
Lopinavir is an anti-Human immunodeficiency virus (HIV) drug which belongs to the class of drugs known as protease inhibitors (PIs) (Raffanti, Haas, 2001). In order to do this, the impurities related to the drug should be initially evaluated with the established threshold levels (ICH 2002) It is the primary responsibility of an analytical chemist to develop and validate the method to meet the requirements of regulatory authorities. Several High Performance Liquid Chromatography (HPLC) methods have been described in the literature for the determination of lopinavir and ritonavir individually (Yekkala et al, 2008; Dias et al, 2005; Faux et al, 2001). Lopinavir impurities (www.usp.org) are: · Impurity-A [chemically N-{1-benzyl-4-[2-(2,6-
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