{"id":24875,"date":"2025-11-03T16:31:36","date_gmt":"2025-11-03T09:31:36","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=24875"},"modified":"2025-11-03T16:35:21","modified_gmt":"2025-11-03T09:35:21","slug":"lisinopril-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/lisinopril-oral-solution\/","title":{"rendered":"Lisinopril Oral Solution"},"content":{"rendered":"

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

Lisinopril Oral Solution<\/p>\n

General Notices<\/p>\n

Action and use\u00a0<\/strong><\/p>\n

Angiotensin converting enzyme inhibitor.<\/p>\n

DEFINITION<\/h2>\n
Lisinopril Oral Solution is a solution of Lisinopril Dihydrate in a suitable aqueous vehicle.<\/p>\n
The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n
Content of anhydrous lisinopril, C_{21<\/sub>H_{31<\/sub>N_{3<\/sub>O_{5<\/sub><\/strong><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
A.\u2003Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1)\u2003Shake a volume of the oral solution with sufficient of a mixture of 20 volumes of water and 80 volumes of methanol to produce a solution containing the equivalent of 0.05% w\/v of anhydrous lisinopril.<\/p>\n
(2)\u20030.055% w\/v of lisinopril dihydrate BPCRS in a mixture of 20 volumes of water and 80 volumes of methanol.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a)\u2003Use as the coating silica gel F254.<\/p>\n
(b)\u2003Pre-wash the plate with methanol and allow to dry in air before use.<\/p>\n
(c)\u2003Use the mobile phase as described below.<\/p>\n
(d)\u2003Apply 20 \u00b5L of each solution.<\/p>\n
(e)\u2003Develop the plate to 15 cm.<\/p>\n
(f)\u2003After removal of the plate, dry in air, spray with a 0.2% w\/v solution of ninhydrin in absolute ethanol, heat at 105\u00b0 for 10 minutes and examine in daylight.<\/p>\n
MOBILE PHASE<\/h3>\n
Equal volumes of glacial acetic acid, butan-1-ol, ethyl acetate and water.<\/p>\n
CONFIRMATION<\/h3>\n
The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n
B.\u2003In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is the same as that of the principal peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Related substances\u00a0<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1)\u2003Dilute a volume of the oral solution containing the equivalent of 5 mg of anhydrous lisinopril to 20 mL with mobile phase A.<\/p>\n
(2)\u2003Dilute 1 volume of solution (1) to 200 volumes with mobile phase A.<\/p>\n
(3)\u2003Dilute 1 volume of solution (2) to 5 volumes with mobile phase A.<\/p>\n
(4)\u2003Heat 20 mg of lisinopril dihydrate BPCRS at 175\u00b0 under nitrogen for 4 hours. Allow to cool and dissolve the residue in 10 mL of mobile phase A (generation of lisinopril diketopiperazine).<\/p>\n
(5)\u2003Boil 20 mL of a 0.1% w\/v solution of lisinopril dihydrate BPCRS in water under a reflux condenser for 2 hours. Allow to cool to room temperature, dilute 5 mL of the resulting solution to 20 mL with mobile phase A and mix thoroughly.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a)\u2003Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography compatible with 100 per cent aqueous mobile phases (4 \u00b5m) (Phenomenex Synergi Hydro-RP is suitable) fitted with a guard column (4 mm \u00d7 3 mm) packed with the same material.<\/p>\n
(b)\u2003Use gradient elution and the mobile phase described below.<\/p>\n
(c)\u2003Use a flow rate of 1.0 mL per minute.<\/p>\n
(d)\u2003Use a column temperature of 35\u00b0.<\/p>\n
(e)\u2003Use a detection wavelength of 210 nm.<\/p>\n
(f)\u2003Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
Mobile phase A 25 volumes of methanol and 75 volumes of a solution prepared by dissolving 13.7 g of sodium dihydrogen orthophosphate, 2.1 g of disodium hydrogen orthophosphate dihydrate and 6.8 g of tetrabutylammonium hydrogen sulfate in 2000 mL of water and adjusting the pH to 5.7 with either 5M sodium hydroxide or orthophosphoric acid.<\/p>\n
Mobile phase B acetonitrile R1.<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/th>\n Mobile phase A (% v\/v)<\/th>\n Mobile phase B (% v\/v)<\/th>\n Comment<\/th>\n<\/tr>\n
0\u201330<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
30\u201331<\/td>\n 100\u219250<\/td>\n 0\u219250<\/td>\n linear gradient<\/td>\n<\/tr>\n
31\u201339<\/td>\n 50<\/td>\n 50<\/td>\n isocratic<\/td>\n<\/tr>\n
39\u201340<\/td>\n 50\u2192100<\/td>\n 50\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
40\u201360<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded under the prescribed conditions, the relative retention with reference to lisinopril (retention time about 8 minutes) is: lisinopril diketopiperazine, about 2.6.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless:<\/p>\n
in the chromatogram obtained with solution (3), the signal-to-noise ratio of the peak due to lisinopril is at least 15; in the chromatogram obtained with solution (5), a peak on the tail of the lisinopril peak is visible.<\/p>\n
LIMITS<\/h3>\n
Identify any peak corresponding to lisinopril diketopiperazine in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (4), and multiply the area of this peak by a correction factor of 1.4.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to lisinopril diketopiperazine is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%);<\/p>\n
the area of any other secondary peak is not greater than 0.6 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n
the sum of the areas of any such peaks is not greater than 1.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.6%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1)\u2003Dilute a weighed quantity of the oral solution containing the equivalent of 5 mg of anhydrous lisinopril to 20 mL with mobile phase A.<\/p>\n
(2)\u20030.027% w\/v of lisinopril dihydrate BPCRS in mobile phase A.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related substances may be used but using isocratic elution and mobile phase A.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C_{21<\/sub>H_{31<\/sub>N_{3<\/sub>O_{5<\/sub>, weight in volume, using the declared content of C_{21<\/sub>H_{31<\/sub>N_{3<\/sub>O_{5<\/sub> in lisinopril dihydrate BPCRS.<\/p>\n}}}}}}}}
LABELLING<\/h2>\n
The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous lisinopril.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Lisinopril Oral Solution General Notices Action and use\u00a0 Angiotensin converting enzyme inhibitor. DEFINITION Lisinopril Oral Solution is a solution of Lisinopril Dihydrate in a suitable aqueous vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of anhydrous lisinopril, C21H31N3O5…<\/p>\n","protected":false},"author":5,"featured_media":24876,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-24875","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\/24875","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=24875"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24875\/revisions"}],"predecessor-version":[{"id":24903,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24875\/revisions\/24903"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24876"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=24875"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=24875"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=24875"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/th>\n	Mobile phase A (% v\/v)<\/th>\n	Mobile phase B (% v\/v)<\/th>\n	Comment<\/th>\n<\/tr>\n
0\u201330<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
30\u201331<\/td>\n	100\u219250<\/td>\n	0\u219250<\/td>\n	linear gradient<\/td>\n<\/tr>\n
31\u201339<\/td>\n	50<\/td>\n	50<\/td>\n	isocratic<\/td>\n<\/tr>\n
39\u201340<\/td>\n	50\u2192100<\/td>\n	50\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
40\u201360<\/td>\n	100<\/td>\n	0<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded under the prescribed conditions, the relative retention with reference to lisinopril (retention time about 8 minutes) is: lisinopril diketopiperazine, about 2.6.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless:<\/p>\n in the chromatogram obtained with solution (3), the signal-to-noise ratio of the peak due to lisinopril is at least 15; in the chromatogram obtained with solution (5), a peak on the tail of the lisinopril peak is visible.<\/p>\n LIMITS<\/h3>\n Identify any peak corresponding to lisinopril diketopiperazine in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (4), and multiply the area of this peak by a correction factor of 1.4.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to lisinopril diketopiperazine is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%);<\/p>\n the area of any other secondary peak is not greater than 0.6 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n the sum of the areas of any such peaks is not greater than 1.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.6%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1)\u2003Dilute a weighed quantity of the oral solution containing the equivalent of 5 mg of anhydrous lisinopril to 20 mL with mobile phase A.<\/p>\n (2)\u20030.027% w\/v of lisinopril dihydrate BPCRS in mobile phase A.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n The chromatographic conditions described under Related substances may be used but using isocratic elution and mobile phase A.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C_{21<\/sub>H_{31<\/sub>N_{3<\/sub>O_{5<\/sub>, weight in volume, using the declared content of C_{21<\/sub>H_{31<\/sub>N_{3<\/sub>O_{5<\/sub> in lisinopril dihydrate BPCRS.<\/p>\n}}}}}}}} LABELLING<\/h2>\n The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous lisinopril.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Lisinopril Oral Solution General Notices Action and use\u00a0 Angiotensin converting enzyme inhibitor. DEFINITION Lisinopril Oral Solution is a solution of Lisinopril Dihydrate in a suitable aqueous vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of anhydrous lisinopril, C21H31N3O5…<\/p>\n","protected":false},"author":5,"featured_media":24876,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-24875","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\/24875","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=24875"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24875\/revisions"}],"predecessor-version":[{"id":24903,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24875\/revisions\/24903"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24876"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=24875"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=24875"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=24875"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

MOBILE PHASE<\/h3>\nEqual volumes of glacial acetic acid, butan-1-ol, ethyl acetate and water.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless:<\/p>\nin the chromatogram obtained with solution (3), the signal-to-noise ratio of the peak due to lisinopril is at least 15; in the chromatogram obtained with solution (5), a peak on the tail of the lisinopril peak is visible.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions described under Related substances may be used but using isocratic elution and mobile phase A.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nDetermine the weight per mL of the oral solution, Appendix V G, and calculate the content of C21<\/sub>H31<\/sub>N3<\/sub>O5<\/sub>, weight in volume, using the declared content of C21<\/sub>H31<\/sub>N3<\/sub>O5<\/sub> in lisinopril dihydrate BPCRS.<\/p>\n

MOBILE PHASE<\/h3>\n
Equal volumes of glacial acetic acid, butan-1-ol, ethyl acetate and water.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless:<\/p>\n
in the chromatogram obtained with solution (3), the signal-to-noise ratio of the peak due to lisinopril is at least 15; in the chromatogram obtained with solution (5), a peak on the tail of the lisinopril peak is visible.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related substances may be used but using isocratic elution and mobile phase A.<\/p>\n