BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Thiazide diuretic.<\/p>\n Hydrochlorothiazide Tablets contain Hydrochlorothiazide.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n Content of hydrochlorothiazide, C7<\/sub>H8<\/sub>ClN3<\/sub>O4<\/sub>S2<\/sub><\/strong><\/p>\n 92.5 to 107.5% of the stated amount.<\/p>\n Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (a) Use as the coating silica gel GF254. ethyl acetate.<\/strong><\/p>\n By each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds in colour and intensity to that in the chromatogram obtained with solution (2).<\/p>\n Related substances<\/strong><\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Shake a quantity of the powdered tablets containing 50 mg of Hydrochlorothiazide with 25 mL of a mixture of equal volumes of acetonitrile and methanol and dilute to 100 mL with phosphate buffer solution pH 3.2 R1. Filter through a glass-fibre filter (Whatman 0.45\u03bc GD\/X is suitable).<\/p>\n (2) Dilute 1 volume of solution (1) to 100 volumes with a mixture containing 1 volume of methanol, 1 volume of acetonitrile and 2 volumes of phosphate buffer solution pH 3.2 R1.<\/p>\n (3) Dissolve, with the aid of ultrasound, 15 mg each of hydrochlorothiazide BPCRS and chlorothiazide BPCRS in 25 mL of a mixture of equal volumes of acetonitrile and methanol and dilute to 100 mL with phosphate buffer solution pH 3.2 R1. Dilute 5 volumes of this solution to 100 volumes with the same solvent mixture.<\/p>\n (4) Dilute 1 volume of solution (2) to 10 volumes with a mixture containing 1 volume of methanol, 1 volume of acetonitrile and 2 volumes of phosphate buffer solution pH 3.2 R1.<\/p>\n (a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 \u03bcm) (Phenosphere ODS 3\u03bc or Microsorb ODS 3\u03bc is suitable). MOBILE PHASE A<\/em><\/p>\n 10 volumes of tetrahydrofuran, 60 volumes of methanol and 940 volumes of phosphate buffer solution pH 3.2 R1.<\/p>\n MOBILE PHASE B<\/em><\/p>\n 50 volumes of tetrahydrofuran, 500 volumes of methanol and 500 volumes of phosphate buffer solution pH 3.2 R1. Equilibrate the column for at least 20 minutes with mobile phase A.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to chlorothiazide and hydrochlorothiazide is at least 2.5.<\/p>\n In the chromatogram obtained with solution (1): Weigh and powder 20 tablets. To a quantity of the powder containing 30 mg of Hydrochlorothiazide add 50 mL of 0.1M sodium hydroxide, shake for 20 minutes and dilute to 100 mL with 0.1M sodium hydroxide. Mix, filter, dilute 5 mL of the filtrate to 100 mL with water and measure the absorbance of the resulting solution at the maximum at 273 nm, Appendix II B. Calculate the content of C7<\/sub>H8<\/sub>ClN3<\/sub>O4<\/sub>S2<\/sub> taking 520 as the value of A(1%, 1 cm) at the maximum at 273 nm.<\/p>\n","protected":false},"excerpt":{"rendered":" BP 2025 (Ph. Eur. 11.6 update) Action and use Thiazide diuretic. DEFINITION Hydrochlorothiazide Tablets contain Hydrochlorothiazide. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of hydrochlorothiazide, C7H8ClN3O4S2 92.5 to 107.5% of the stated amount. IDENTIFICATION Carry out the method for thin-layer chromatography, Appendix III A, using the following…<\/p>\n","protected":false},"author":5,"featured_media":18802,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-18761","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\/18761","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=18761"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18761\/revisions"}],"predecessor-version":[{"id":18813,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18761\/revisions\/18813"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/18802"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=18761"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=18761"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=18761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
\n(1) Triturate a quantity of the powdered tablets containing 10 mg of Hydrochlorothiazide with 10 mL of acetone and filter.
\n(2) 0.1% w\/v of hydrochlorothiazide BPCRS in acetone.<\/p>\nCHROMATOGRAPHIC CONDITIONS<\/h3>\n
\n(b) Use the mobile phase as described below.
\n(c) Apply 5 \u03bcL of each solution.
\n(d) Develop the plate to 15 cm.
\n(e) After removal of the plate, dry in a current of air, examine under ultraviolet light (254 nm) and then treat the plate by Method I and examine again.<\/p>\nMOBILE PHASE<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
\n(b) Use gradient elution and the mobile phases described below.
\n(c) Use a flow rate of 0.8 mL per minute.
\n(d) Use an ambient column temperature.
\n(e) Use a detection wavelength of 224 nm.
\n(f) Inject 20 \u03bcL of each solution.<\/p>\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 \n 0-17<\/td>\n 100\u219255<\/td>\n 0\u219245<\/td>\n linear gradient<\/td>\n<\/tr>\n \n 17-30<\/td>\n 55<\/td>\n 45<\/td>\n isocratic<\/td>\n<\/tr>\n \n 30-35<\/td>\n 55\u2192100<\/td>\n 45\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n \n 35-50<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \nSYSTEM SUITABILITY<\/h3>\n
LIMITS<\/h3>\n
\nthe area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);
\nthe sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).
\nDisregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\nASSAY<\/h2>\n