Determination of Exemestane in bulk and pharmaceutical dosage form by HPTLC

Mane, Maya B.; Sangshetti, Jaiprakash N.; Wavhal, Parmeshwar; Wakte, Pravin; Shinde, Devanand B.

doi:10.1016/j.arabjc.2010.11.009

Cited by 9 publications

(3 citation statements)

References 3 publications

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“…Exemestane has been determined by different analytical techniques such as LC-MS [5][6][7][8][9], GC-MS [10], LC-radio immunoassay [11], UVspectrophotometry [12], HPTLC [13] and UPLC [14].…”

Section: Introductionmentioning

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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“…Exemestane has been determined by different analytical techniques such as LC-MS [5][6][7][8][9], GC-MS [10], LC-radio immunoassay [11], UVspectrophotometry [12], HPTLC [13] and UPLC [14].…”

Section: Introductionmentioning

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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“…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.…”

Section: Introductionmentioning

confidence: 99%

Quantification of Exemestane Accumulation During Microbial Bioconversion by TLC Image Analysis

Patil

Sharma

Banerjee

et al. 2017

Int J Pharm Pharm Sci

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Objective: The present study was aimed at developing a rapid, cost effective and accurate method for quantification of exemestane using thin layer chromatography (TLC) separation followed by image analysis and to test it for monitoring the accumulation of exemestane during microbial bioconversion. Methods:After microbial bioconversion and TLC separation of products formed, exemestane was quantified using ImageQuant TL v2003 image analysis software and the results were compared with high performance liquid chromatography (HPLC) analysis. Results:The percentage error between TLC and HPLC analyses was ranged from (-) 5.18 to (+) 5.51. Bacterial strains Arthrobacter simplex IAM 1660, Nocardia sp. MTCC 1534, Pseudomonas putida MTCC 1194 and Rhodococcus rhodochorus MTCC 291 respectively yielded 79.7 (72 h), 63.9 (72 h), 69.8 (96 h) and 83.2 (96 h) mole percent bioconversion of 6-methylene androstenedione to exemestane. Conclusion:Rhodococcus rhodochorus MTCC 291 was found to be the most suitable organism for the bioconversion and may be used to develop an eco-friendly route to replace chemical synthesis that eliminates the use of toxic chemicals and side products.

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“…Literature survey reports that Exemestane can be determined by different analytical techniques such as HPTLC 5 , UV-spectrophotometry 6 , GC-MS 7 , LC-MS [8][9][10][11][12] , LC-radio immuno assay 13 , HPLC [14][15][16][17] and UPLC 18 in pharmaceutical dosage forms and in biological fluids. So far only two stability indicating HPLC [19][20] methods were reported for the determination of Exemestane and at present the authors have proposed a robust, precise and accurate stability indicating liquid chromatographic method for the determination of Exemestane in pharmaceutical dosage forms.…”

Section: Introductionmentioning

confidence: 99%

A Validated Stability-Indicating Liquid Chromatographic Method for the Determination of Exemestane

2014

Chem Sci Trans

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A stability indicating liquid chromatographic method was developed for the determination of Exemestane in presence of degradation products using Zorbax SB C18 (150 mm × 4.6 mm i. d., 3.5 µm particle size) column with a flow rate 1.2 mL/min (UV detection 247 nm). Linearity was observed over a concentration range 0.1-200 μg/mL with regression equation y = 56288 x -3004 (R 2 = 0.999). Forced degradation studies were performed and Exemestane is reported to be highly sensitive towards oxidation. The method was validated as per ICH guidelines.

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Determination of Exemestane in bulk and pharmaceutical dosage form by HPTLC

Cited by 9 publications

References 3 publications

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

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

Quantification of Exemestane Accumulation During Microbial Bioconversion by TLC Image Analysis

A Validated Stability-Indicating Liquid Chromatographic Method for the Determination of Exemestane

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