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
Related Articles
- EP ID EP108687
- DOI -
- Views 114
- Downloads 0
MANAGEMENT OF MALE INFERTILITY: AYURVEDIC APPROACH
An estimated 5-10 percent of couples are classified as infertile, which means that they have been trying to get pregnant with frequent, unprotected intercourse for at least a year with no success. In about half the cases...
EMULGEL: A COMPREHENSIVE REVIEW ON THE RECENT ADVANCES IN TOPICAL DRUG DELIVERY
Emulgel has emerged as a promising drug delivery system for the delivery of hydrophobic drugs. When gel and emulsion are used in combined form they are referred as Emulgel. Emulsion in gel have emerged as one of the most...
ORAL MULTIPARTICULATE PULSATILE DRUG DELIVERY SYSTEMS: A REVIEW
Pulsatile drug delivery aims to release drugs in a planned pattern i.e. at appropriate time and/or at a suitable site of action. Pharmaceutical invention and research are increasingly focusing on delivery systems which e...
ASSESSMENT OF PHYTOCHEMICAL AND PHARMACOLOGICAL PROPERTIES OF ETHANOLIC EXTRACT OF CERBERA MANGHAS L. LEAVES
The objective of the present study was to investigate the phytochemical nature (group determination of plant constituents) as well as the antioxidant and analgesic activity of ethanolic extract of the Cerbera manghas L....
COMPARATIVE STUDY OF ORAL L-ARGININE THERAPY VERSUS NON-AMBULATORY TREATMENT IN PREGNANCY WITH ASYMMETRICAL FETAL GROWTH RESTRICTION
L-arginine is a unique molecule that produces nitric oxide in body and plays a crucial role in physiological hemodynamic modification in pregnancy. A randomised comparative prospective study was carried out in a maternit...