Development and Validation of Stability Indicating Method for the Determination of Exemestane by Reverse Phase High Performance Liquid Chromatography

Konda, Bharath; Tiwari, Rishabh; Fegade, Harshal

doi:10.1093/chrsci/49.8.634

Cited by 12 publications

(6 citation statements)

References 12 publications

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“…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.…”

Section: Introductionsupporting

confidence: 54%

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

Gupta,

Sharma,

Gupta

et al. 2024

ACS Omega

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The present study describes the development and validation of a simple and rapid HPLC method for the simultaneous quantification of exemestane and thymoquinone. The separation of both compounds was performed on a 5 μ C-18 column utilizing phase A as water/methanol (45:5 v/v) and phase B as acetonitrile (50 v/v) (total ratio of A/B = 40:60 v/v) in isocratic elution mode as the mobile phase at a flow rate of 0.8 mL/min. Further, the Box−Behnken design was used for optimizing the analytical method. The proposed method was validated for various parameters, and all parameters were found to be within an acceptable range. The simultaneous detection of both drugs was monitored at 243 nm with a retention time of 5.73 and 6.93 min, respectively. Moreover, the forced degradation studies were conducted under various stress conditions, and the relevance of the validated RP-HPLC method was further explored for the estimation of drugs from lipid-based nanoformulation. Taken together, the study construed the development of an efficient and robust method that could be used for the quantification of these agents in various in vitro as well as in vivo models.

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Section: Introductionsupporting

confidence: 54%

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

Gupta,

Sharma,

Gupta

et al. 2024

ACS Omega

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“…EXE concentration was quantified with the reversed-phase high-performance liquid chromatography apparatus (RP-HPLC; Shimadzu, Tokyo, Japan) attached to the UV detector. The RP-HPLC technique was reproduced as per the published report by Konda et al [26]. A C-18 column (Li Chospher 100; 250×4.6 mm dimension with 5 μm particle size) was employed for the chromatographic separation at 30 °C.…”

Section: Quantification Of Exe In Exe-tpgs-plhnpsmentioning

confidence: 99%

Exemestane encapsulated polymer-lipid hybrid nanoparticles for improved efficacy against breast cancer: optimization, in vitro characterization and cell culture studies

et al. 2021

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Polymer-lipid hybrid nanoparticles (PLHNPs) are novel nanoplatforms for the effective delivery of a lipophilic drug in the management of a variety of solid tumors. The present work was designed to develop exemestane (EXE) encapsulated D-alpha-tocopheryl polyethylene glycol succinate (TPGS) based PLHNPs (EXE-TPGS-PLHNPs) for controlled delivery of EXE for breast cancer management. EXE-TPGS-PLHNPs were formulated by single-step nano-precipitation technique and statistically optimized by a 33 Box–Behnken design using Design expert® software. The polycaprolactone (PCL; X 1), phospholipon 90 G (PL-90G; X 2), and surfactant (X 3) were selected as independent factors while particles size (PS; Y 1), polydispersity index (PDI; Y 2), and %entrapment efficiency (%EE; Y 3) were chosen as dependent factors. The average PS, PDI, and %EE of the optimized EXE-TPGS-PLHNPs was observed to be 136.37 ± 3.27 nm, 0.110 ± 0.013, and 88.56 ± 2.15% respectively. The physical state of entrapped EXE was further validated by Fourier-transform infrared spectroscopy, differential scanning calorimetry, and powder x-ray diffraction that revealed complete encapsulation of EXE in the hybrid matrix of PLHNPs with no sign of significant interaction between drug and excipients. In vitro release study in simulated gastrointestinal fluids revealed initial fast release for 2 h after that controlled release profile up to 24 h of study. Moreover, optimized EXE-TPGS-PLHNPs exhibited excellent stability in gastrointestinal fluids as well as colloidal stability in different storage concentrations. Furthermore, EXE-TPGS-PLHNPs exhibited distinctively higher cellular uptake and time and dose-dependent cytotoxicity against MCF-7 breast tumor cells compared to EXE-PLHNPs without TPGS and free EXE. The obtained results suggested that EXE-TPGS-PLHNPs can be a promising platform for the controlled delivery of EXE for the effective treatment of breast cancer.

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“…Till now only two stability indicating HPLC methods are available in the literature in which Bharath et al [20] developed a stability indicating method in which UV detector was used and the retention time of Exemestane was at around 7.0 minutes. Mathrusri Annapurna et al [21] observed the elution of Exemestane at about 4.5 minutes using phosphate buffer and acetonitrile mixture. In the present study the authors have proposed a new simple, economical and robust stability indicating liquid chromatographic method (Isocratic mode) for the determination of Exemestane in pharmaceutical dosage forms (Tablets).…”

Section: Breda Et Al Developed a Hplc Methods In Plasma By Highperfor...mentioning

confidence: 99%

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

Mukthinuthalapati¹,

Venkatesh²

2015

J Bioequiv Availab

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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.

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Development and Validation of Stability Indicating Method for the Determination of Exemestane by Reverse Phase High Performance Liquid Chromatography

Cited by 12 publications

References 12 publications

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

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

Exemestane encapsulated polymer-lipid hybrid nanoparticles for improved efficacy against breast cancer: optimization, in vitro characterization and cell culture studies

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

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