{"id":14998,"date":"2025-10-16T11:26:39","date_gmt":"2025-10-16T04:26:39","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14998"},"modified":"2025-10-16T11:26:39","modified_gmt":"2025-10-16T04:26:39","slug":"eplerenone-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/eplerenone-tablets\/","title":{"rendered":"Eplerenone Tablets"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

General Notices<\/p>\n

Action and use<\/strong><\/p>\n

Aldosterone receptor antagonist; antihypertensive.<\/p>\n

DEFINITION<\/h2>\n
Eplerenone Tablets contain Eplerenone.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n
Content of eplerenone, C24H30O6<\/p>\n
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
Shake a quantity of powdered tablets containing 50 mg of Eplerenone with 25 mL of dichloromethane and filter. Evaporate the filtrate to dryness on a water-bath. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectra of eplerenone EPCRS which has been treated in the same manner.<\/p>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.
(b) Use 900 mL of 1% w\/v sodium dodecyl sulfate in 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n
PROCEDURE<\/h4>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
Solution B 25 volumes of acetonitrile, 25 volumes of methanol and 50 volumes of water.<\/p>\n
(1) After 30 minutes withdraw a sample of the medium and filter. Dilute the filtrate, if necessary, with 0.1M hydrochloric acid to produce a solution expected to contain 0.0028% w\/v of Eplerenone.
(2) 0.0028% w\/v of eplerenone EPCRS in 0.1M hydrochloric acid.
(3) 0.025% w\/v of eplerenone for system suitability EPCRS in Solution B.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography R (3 \u00b5m) (Inertsil ODS-3 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use a column temperature of 30\u00b0.
(e) Use a detection wavelength of 240 nm.
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
46 volumes of solution A and 54 volumes of a 0.1% v\/v solution of orthophophoric acid.<\/p>\n
When the chromatograms are recorded under the prescribed conditions, the relative retention with reference to eplerenone (retention time about 9.3 minutes) are: impurity D, about 0.71 and impurity A, about 0.74.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 5.0, where Hp is the height above the baseline of the peak due to impurity D and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity A.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of eplerenone, C24H30O6, in the medium from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n
LIMITS<\/h4>\n
The amount of eplerenone released is not less than 75% (Q) of the stated amount.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Shake a quantity of powdered tablets containing 25 mg of Eplerenone with 40 mL of solution B, add sufficient solution B to produce 50mL and filter.
(2) Dilute 1 volume of solution (1) to 100 volumes with Solution B. Further dilute 1 volume of this solution to 5 volumes with the same solvent.
(3) 0.05% w\/v of eplerenone for system suitability EPCRS in Solution B.
(4) 0.05% w\/v of eplerenone for peak identification EPCRS in 0.01M hydrochloric acid.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography R (3 \u00b5m) (Inertsil ODS-3 is suitable).
(b) Use gradient elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use a column temperature of 30\u00b0.
(e) Use a detection wavelength of 240 nm.
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 0.1% v\/v solution of orthophophoric acid.<\/p>\n
Mobile phase B 0.1 volumes of orthophophoric acid, 40 volumes of acetonitrile and 60 volumes of methanol.<\/p>\n
Time (Minutes) Mobile phase A (% v\/v) Mobile phase B (% v\/v) Comment<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/td>\n Mobile phase A (% v\/v)<\/td>\n Mobile phase B (% v\/v)<\/td>\n Comment<\/td>\n<\/tr>\n
0-25<\/td>\n 54<\/td>\n 46<\/td>\n isocratic<\/td>\n<\/tr>\n
25-32<\/td>\n 54\u219240<\/td>\n 46\u219260<\/td>\n linear gradient<\/td>\n<\/tr>\n
32-45<\/td>\n 40<\/td>\n 60<\/td>\n isocratic<\/td>\n<\/tr>\n
45-46<\/td>\n 40\u219254<\/td>\n 60\u219246<\/td>\n linear gradient<\/td>\n<\/tr>\n
46-55<\/td>\n 54<\/td>\n 46<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to eplerenone (retention time about 9 minutes) are: impurity D, about 0.71; impurity A, about 0.74 and impurity B, about 1.2.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless:<\/p>\n
In the chromatogram obtained with solution (3):
the peak-to-valley ratio is at least 5.0, where Hp is the height above the baseline of the peak due to impurity D and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity A.<\/p>\n
LIMITS<\/h4>\n
Identify any peak corresponding to impurities A and D in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and any peak corresponding to impurity B using the chromatogram obtained with solution (4).<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity D is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n
the area of any peak corresponding to impurity A or impurity B is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n
the sum of the areas of all secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1%).<\/p>\n
Disregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n
ASSAY<\/h2>\n
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
Solution B 25 volumes of acetonitrile, 25 volumes of methanol and 50 volumes of water.<\/p>\n
(1) Shake a quantity of powdered tablets containing 25 mg of Eplerenone with 40 mL of Solution B, add sufficient Solution B to produce 50mL and filter. Dilute 1 volume of the filtrate to 10 volumes with Solution B.
(2) 0.005% w\/v of eplerenone EPCRS in Solution B.
(3) 0.05% w\/v of eplerenone for system suitability EPCRS in Solution B.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic conditions described under Dissolution may be used.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 5.0, where Hp is the height above the baseline of the peak due to impurity D and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity A.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of eplerenone, C24H30O6, in the tablets from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Eplerenone.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Aldosterone receptor antagonist; antihypertensive. DEFINITION Eplerenone Tablets contain Eplerenone. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of eplerenone, C24H30O6 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of powdered tablets containing 50…<\/p>\n","protected":false},"author":5,"featured_media":15000,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-14998","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14998","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=14998"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14998\/revisions"}],"predecessor-version":[{"id":15012,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14998\/revisions\/15012"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/15000"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14998"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14998"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/td>\n	Mobile phase A (% v\/v)<\/td>\n	Mobile phase B (% v\/v)<\/td>\n	Comment<\/td>\n<\/tr>\n
0-25<\/td>\n	54<\/td>\n	46<\/td>\n	isocratic<\/td>\n<\/tr>\n
25-32<\/td>\n	54\u219240<\/td>\n	46\u219260<\/td>\n	linear gradient<\/td>\n<\/tr>\n
32-45<\/td>\n	40<\/td>\n	60<\/td>\n	isocratic<\/td>\n<\/tr>\n
45-46<\/td>\n	40\u219254<\/td>\n	60\u219246<\/td>\n	linear gradient<\/td>\n<\/tr>\n
46-55<\/td>\n	54<\/td>\n	46<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to eplerenone (retention time about 9 minutes) are: impurity D, about 0.71; impurity A, about 0.74 and impurity B, about 1.2.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless:<\/p>\n In the chromatogram obtained with solution (3): the peak-to-valley ratio is at least 5.0, where Hp is the height above the baseline of the peak due to impurity D and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity A.<\/p>\n LIMITS<\/h4>\n Identify any peak corresponding to impurities A and D in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and any peak corresponding to impurity B using the chromatogram obtained with solution (4).<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity D is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n the area of any peak corresponding to impurity A or impurity B is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n the sum of the areas of all secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1%).<\/p>\n Disregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n ASSAY<\/h2>\n Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n Solution B 25 volumes of acetonitrile, 25 volumes of methanol and 50 volumes of water.<\/p>\n (1) Shake a quantity of powdered tablets containing 25 mg of Eplerenone with 40 mL of Solution B, add sufficient Solution B to produce 50mL and filter. Dilute 1 volume of the filtrate to 10 volumes with Solution B. (2) 0.005% w\/v of eplerenone EPCRS in Solution B. (3) 0.05% w\/v of eplerenone for system suitability EPCRS in Solution B.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h4>\n The chromatographic conditions described under Dissolution may be used.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 5.0, where Hp is the height above the baseline of the peak due to impurity D and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to impurity A.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the content of eplerenone, C24H30O6, in the tablets from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Eplerenone.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Aldosterone receptor antagonist; antihypertensive. DEFINITION Eplerenone Tablets contain Eplerenone. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of eplerenone, C24H30O6 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of powdered tablets containing 50…<\/p>\n","protected":false},"author":5,"featured_media":15000,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-14998","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14998","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=14998"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14998\/revisions"}],"predecessor-version":[{"id":15012,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14998\/revisions\/15012"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/15000"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14998"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14998"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Dissolution<\/h3>\nComply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.(b) Use 900 mL of 1% w\/v sodium dodecyl sulfate in 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the total content of eplerenone, C24H30O6, in the medium from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n

LIMITS<\/h4>\nThe amount of eplerenone released is not less than 75% (Q) of the stated amount.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\nThe chromatographic conditions described under Dissolution may be used.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the content of eplerenone, C24H30O6, in the tablets from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n

Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.
(b) Use 900 mL of 1% w\/v sodium dodecyl sulfate in 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of eplerenone, C24H30O6, in the medium from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n

LIMITS<\/h4>\n
The amount of eplerenone released is not less than 75% (Q) of the stated amount.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic conditions described under Dissolution may be used.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of eplerenone, C24H30O6, in the tablets from the chromatograms obtained and using the declared content of C24H30O6 in eplerenone EPCRS.<\/p>\n