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Abstract
Flibanserin (Addyi) is a medication used to treat women who have not gone through menopause who have low sexual desire. Specific and simple stability indicating method was developed and validated by high-performance liquid chromatography (RP-HPLC) for the determination of Flibanserin. Separation was carried out by using a mobile phase consisting of 0.01M Potassium phosphate monohydrate buffer (KH2PO4) pH 3.50 buffer: Acetonitrile in the ratio of 60:40. The column used was Agilent C18, (150×4.6) mm, 5µm with a flow rate of 1.0ml/min and temperature at 30°C. The detection was carried out at 248 nm and Flibanserin was eluted at around 2.8min. This method was validated as per ICH guidelines and validation included specificity, precision, linearity, accuracy, forced degradation, and robustness. Forced degradation was conducted under the conditions of hydrolysis, oxidation, thermal, acid, base, and peroxide hydrolysis. The calibration curve was linear over the concentration range from 20 to 200µg/mL and the coefficient of determination (r2) was observed as 0.9998. The precision and accuracy of the method were within the acceptable range. The results of this study showed that the validated method is simple and accurate, which confirmed that the method is suitable for the determination of Flibanserin.
Highlights
Flibanserin (Fig. 1) is a 5-HT1A receptor agonist and a 5-HT2A receptor antagonist that is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.[1]
Method validation showed that the method is sensitive, precise, and accurate with a short analysis time
The Flibanserin drug is liable to degradation in Acid and Peroxide conditions by 3.52 and 5.80 percentages respectively
Summary
Flibanserin (Fig. 1) is a 5-HT1A receptor agonist and a 5-HT2A receptor antagonist that is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.[1]. It has no chiral centers and does not form stereoisomers. It has good aqueous solubility at acidic pH values but is practically insoluble at neutral and basic pH.[1]. This study aims to develop and validate rapid and simple stability indicating reverse-phase high-performance liquid chromatographic method for the determination of Flibanserin. Many analytical techniques had been published for quantitation of Flibanserin in biological fluids[2,3,4,5,6,7,8,9] and spectrophotometric techniques were described.[10,11,12,13]. Very few methods[14,15] are reported in the literature, and no stability-indicating methods are available in the official compendia using RP-HPLC for analysis of Flibanserin. The advantages of current research work have shorter run time, information about degradation study, and complete validation performed following the international guidelines when compared with published journals.[14]. The advantages of the forced degradation study propose shelf life of the product without real-time stability data and support identification of root cause during out of specification, out of trend, and lab investigations
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