A Novel Validated Stability-Indicating RP-HPLC Method for the Determination of Exemestane (Steroidal Aromatase Inhibitor)

Abstract

Background: Exemestane is an active irreversible lipophilic steroidal aromatase inhibitor used to treat breast cancer in addition to surgery and/or radiation in post-menopausal women. It is a white to slightly yellow crystalline powder with a molecular weight of 296.41. Exemestane is freely soluble in N, N-dimethyl formamide, soluble in methanol, and practically insoluble in water. The present robust RP-HPLC method supports the quantitative analysis of Exemestane in pharmaceutical formulations and for carrying out the forced degradation studies.Methods: A novel stability indicating liquid chromatographic method was developed for the determination of Exemestane using HPLC system of Shimadzu Model CBM-20A/20 Alite, equipped with SPD M20A prominence PDA and Zorbax SB C18 (150 mm × 4.6 mm i.d., 3.5 µm particle size) column. A mixture of sodium acetate buffer and acetonitrile (30:70, v/v) was used as a mobile phase with 1.0 ml/min flow rate and the method was validated as per ICH guidelines. Forced degradation studies were performed in different stress conditions such as acidic, basic, oxidation and thermal degradations. Results:The proposed liquid chromatographic method has shown linearity over a concentration range 0.1-200 μg/ml with regression equation y = 59411x -7316 with correlation coefficient 0.999. During the validation process i.e. the intra-day and inter-day precision studies, accuracy and robustness studies the method has shown an RSD of less than 2.0 %. Exemestane is found to be more stable during all the degradation studies because the percentage of degradation was reported to be less than 10. Conclusions:The proposed method was found to be precise, accurate and robust and it can be applied for the determination of Exemestane in any formulations.

Development and Validation of a Robust RP-HPLC Method for the Simultaneous Analysis of Exemestane and Thymoquinone and Its Application to Lipid-Based Nanoformulations

“…The individual quantification of EXE by the HPLC method has been reported at various wavelengths, such as 242, 247, 249, and 250 nm, in the literature. − Likewise, the individual quantification of THY has been reported at 250 and 254 nm. , In our method, during the scanning, the maximum wavelength of detection was found to be 244 nm for EXE and 253 nm for THY, respectively. Therefore, to mitigate the hurdles associated with the previously reported methods, we have developed an efficient and validated method as per the ICH guidelines for the simultaneous estimation of EXE and THY on 243 nm wavelength in considering to achieve optimum sensitivities for both compounds.…”

Rapid Analytical Method Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Exemestane and Genistein with Specific Application in Lipid-Based Nanoformulations

“…Then, filtration through syringe filters (0.2 μm) was done, followed by further analysis which was performed by injecting the sample solution into the HPLC chromatographic system. 23 2.1.6. Application of the Simultaneous Analytical Method in Nanoformulations.…”

“…After sealing, the volumetric flask was exposed to direct sunlight for 30 min to study the photochemical stability. Then, filtration through syringe filters (0.2 μm) was done, followed by further analysis which was performed by injecting the sample solution into the HPLC chromatographic system …”

Quantification of Exemestane Accumulation During Microbial Bioconversion by TLC Image Analysis

“…Number of methods have been employed for quantification of exemestane in samples of human urine by gas chromatography/mass spectrometry [14][15] and liquid chromatography/tandem mass spectrometry [16], in human plasma by LC-MSMS [17], in various pharmaceutical dosage forms and stability testing by HPTLC, HPLC and RP-HPLC [18][19][20][21][22]. All these methods are time-consuming and involve sophisticated instrumentation.…”