{"id":20980,"date":"2025-10-27T17:28:28","date_gmt":"2025-10-27T10:28:28","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20980"},"modified":"2025-10-27T17:28:28","modified_gmt":"2025-10-27T10:28:28","slug":"sertraline-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/sertraline-tablets\/","title":{"rendered":"Sertraline Tablets"},"content":{"rendered":"

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

Selective serotonin reuptake inhibitor; antidepressant.<\/p>\n

DEFINITION<\/h2>\n

Sertraline Tablets contain Sertraline Hydrochloride.<\/p>\n

The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n

Content of sertraline, C17<\/sub>H17<\/sub>Cl2<\/sub>N<\/strong><\/p>\n

95.0 to 105.0% of the stated amount.<\/p>\n

IDENTIFICATION<\/h2>\n

Shake a quantity of the powdered tablets containing the equivalent of 0.22 g of sertraline with 10 mL of absolute ethanol for 10 minutes and filter. Evaporate the filtrate to dryness and dry the residue at 60\u00b0 under vacuum for 1 hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with reference spectrum A of sertraline hydrochloride (RS 460). If the spectrum thus obtained is not concordant, record a solution spectrum using a 1.0% w\/v solution of the residue obtained above in dichloromethane. The infrared absorption spectrum of the resulting solution, Appendix II A, is concordant with reference spectrum B of sertraline hydrochloride (RS 443).<\/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 75 revolutions per minute.<\/p>\n

(b) Use 900 mL of sodium acetate buffer solution pH 4.5, at a temperature of 37\u00b0, as the medium.<\/p>\n

PROCEDURE<\/p>\n

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n

(1) After 30 minutes withdraw a 10-mL sample of the medium and filter (Whatman GF\/C is suitable), discard the first 5 mL of filtrate.<\/p>\n

(2) 0.0056% w\/v of sertraline hydrochloride BPCRS in dissolution medium.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n

(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (4 \u03bcm) (Novapak C18 is suitable).<\/p>\n

(b) Use isocratic elution and the mobile phase described below.<\/p>\n

(c) Use a flow rate of 1.8 mL per minute.<\/p>\n

(d) Use a column temperature 30\u00b0.<\/p>\n

(e) Use a detection wavelength of 265 nm.<\/p>\n

(f) Inject 20 \u03bcL of each solution.<\/p>\n

MOBILE PHASE<\/h4>\n

15 volumes of methanol, 40 volumes of a solution containing 0.286% v\/v glacial acetic acid and 0.348% v\/v triethylamine and 45 volumes of acetonitrile.<\/p>\n

When the chromatograms are recorded under the prescribed conditions the retention time of sertraline is about 2 minutes.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n

Calculate the content of sertraline, C17<\/sub>H17<\/sub>Cl2<\/sub>N, in the medium using the declared content of C17<\/sub>H17<\/sub>Cl2<\/sub>N,HCl in sertraline hydrochloride BPCRS. Each mg of C17<\/sub>H17<\/sub>Cl2<\/sub>N,HCl is equivalent to 0.8936 mg of C17<\/sub>H17<\/sub>Cl2<\/sub>N.<\/p>\n

LIMITS<\/h4>\n

The amount of sertraline released after 30 minutes 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

Solution A 30 volumes of acetonitrile and 70 volumes of water.<\/p>\n

(1) Shake a quantity of whole tablets containing the equivalent of 0.45 g of sertraline with 150 mL of solution A until fully dispersed. Mix for 5 minutes with the aid of ultrasound and add sufficient solvent A to produce 200 mL, mix and filter (Whatman PVDF is suitable), discarding the first 5 mL of filtrate.<\/p>\n

(2) Dilute 1 volume of solution (1) to 500 volumes with solution A.<\/p>\n

(3) 0.001% w\/v of (R)-mandelic acid in solution A.<\/p>\n

(4) 0.25% w\/v of sertraline hydrochloride impurity standard BPCRS in solution A.<\/p>\n

(5) Dilute 1 volume of solution (2) to 2 volumes with solution A.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n

(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Symmetry C18 is suitable).<\/p>\n

(b) Use gradient elution and the mobile phase described below.<\/p>\n

(c) Use a flow rate of 1.0 mL per minute.<\/p>\n

(d) Use an ambient column temperature.<\/p>\n

(e) Use a detection wavelength of 210 nm.<\/p>\n

(f) Inject 20 \u03bcL of each solution.<\/p>\n

MOBILE PHASE<\/h4>\n

Mobile phase A: 0.272% w\/v of potassium dihydrogen orthophosphate in water, adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n

Mobile phase B: acetonitrile R1<\/p>\n\n\n\n\n\n\n\n
Time (Minutes)\u00a0<\/strong><\/td>\nMobile phase A (% v\/v)\u00a0<\/strong><\/td>\nMobile phase B (% v\/v)\u00a0<\/strong><\/td>\nComment<\/strong><\/td>\n<\/tr>\n
0-30<\/td>\n70<\/td>\n30<\/td>\nisocratic<\/td>\n<\/tr>\n
30-40<\/td>\n70\u219260<\/td>\n30\u219240<\/td>\nlinear gradient<\/td>\n<\/tr>\n
40-41<\/td>\n60\u219270<\/td>\n40\u219230<\/td>\nlinear gradient<\/td>\n<\/tr>\n
41-50<\/td>\n70<\/td>\n30<\/td>\nre-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

SYSTEM SUITABILITY<\/h4>\n

The test is not valid unless the chromatogram obtained with solution (4) closely resembles the reference chromatogram supplied with sertraline hydrochloride impurity standard BPCRS.<\/p>\n

LIMITS<\/h4>\n

In the chromatogram obtained with solution (1):<\/p>\n

the area of any peak corresponding to impurity C is not greater than 4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.8%);<\/p>\n

the area of any peak corresponding to (R)-mandelic acid is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.4%);<\/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 total impurity content, excluding impurity C, is not greater than 1.5%.<\/p>\n

Disregard any peak with an area less than that of the principal peak in the chromatogram obtained with solution (5) (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

(1) Mix for 45 minutes with the aid of ultrasound a quantity of the powdered tablets containing the equivalent of 0.19 g of sertraline with 150 mL of mobile phase, shake for 30 minutes, cool, add sufficient water to produce 200 mL, mix and filter (Whatman GF\/C is suitable), discarding the first 5 mL of filtrate. Dilute 1 volume of the filtrate to 20 volumes with mobile phase.<\/p>\n

(2) 0.005% w\/v of sertraline hydrochloride BPCRS in the mobile phase.<\/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 C17<\/sub>H17<\/sub>Cl2<\/sub>N in the tablets using the declared content of C17<\/sub>H17<\/sub>Cl2<\/sub>N,HCl in sertraline hydrochloride BPCRS. Each mg of C17<\/sub>H17<\/sub>Cl2<\/sub>N,HCl is equivalent to 0.8936 mg of C17<\/sub>H17<\/sub>Cl2<\/sub>N.<\/p>\n

LABELLING<\/h2>\n

The quantity of the active ingredient is stated in terms of the equivalent amount of sertraline.<\/p>\n

IMPURITIES<\/h2>\n

The impurities limited by the requirements of this monograph include impurities B, C and E listed under Sertraline Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"

Action and use Selective serotonin reuptake inhibitor; antidepressant. DEFINITION Sertraline Tablets contain Sertraline Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of sertraline, C17H17Cl2N 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of the powdered tablets containing the equivalent of 0.22 g of sertraline…<\/p>\n","protected":false},"author":4,"featured_media":20990,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20980","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\/20980","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=20980"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20980\/revisions"}],"predecessor-version":[{"id":20992,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20980\/revisions\/20992"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20990"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20980"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20980"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20980"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}