Abstract
Objective: This work makes an attempt to establish a sensitive and accurate method for the development and validation of an analytical method for estimation of ulipristal acetate (UPA) in bulk and pharmaceutical dosage form.
 Methods: A mixture of 20 mM acetate buffer pH 3.7 and methanol in the ratio of 70:30 (v/v %) was used as the mobile phase. An xBridge™ C18 column (250 mm × 4.6 mm, 5μ) was used for the analysis at a flow rate of 1 ml/min, injection volume of 20 μl, run time of 15 min, and detection wavelength of 309 nm. The repeatability (within-day in triplicates) and intermediate precision (for 2 days) were carried out by six injections and the obtained results within and between the days of trials were expressed as percent relative standard deviation (% RSD). The linearity of the method was determined by the analysis of analyte concentration across a range of 10 μg/ml–60 μg/ml.
 Results: The % RSD values of precision studies were found to be below the accepted limit of 2%. The method was found to be linear with a correlation coefficient (R2) of 0.98. The method was also found to be accurate and robust with suitable values. Limit of detection (LOD) and limit of quantification (LOQ) of the method were found to be 0.371 μg/ml and 1.23 μg/ml, respectively.
 Conclusion: The results of analysis prove that this method can be used for the routine determination of UPA in bulk drug and in pharmaceutical dosage forms.
Highlights
The most common benign gynecological tumors in women during reproductive years are uterine fibroids
Uterine fibroids are symptomatic in 20–40% of women [1]
MATERIALS AND METHODS Materials HPLC grade methanol and glacial acetic acid and sodium acetate were procured from Merck Life Science Private Limited, Mumbai, India
Summary
The most common benign gynecological tumors in women during reproductive years are uterine fibroids. Uterine fibroids are symptomatic in 20–40% of women [1]. A majority of women are asymptomatic and many uterine fibroids go undiagnosed [2]. Evidence suggests that they may arise by somatic mutation [3,4]. The indication of a genetic link can be understood from the fact that Caucasian women have a lower risk of developing fibroids than AfricanAmerican women [5,6]. The risk of infertility, miscarriage, premature deliveries, and complications in late pregnancy are higher in women with fibroids [12]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Asian Journal of Pharmaceutical and Clinical Research
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
