Cyclopenthiazide Tablets
Action and use
Thiazide-like diuretic.
Definition
Cyclopenthiazide Tablets contain Cyclopenthiazide.
Content of cyclopenthiazide, C13H18ClN3O4S2
90.0 to 110.0% of the stated amount.
Identification
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
By each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Cyclopenthiazide comply with the requirements stated under Tablets using the following method of analysis. To one tablet add 50 mL of methanol, shake for 20 minutes, filter and measure the absorbance of the filtrate at the maximum at 273 nm, Appendix II B. Calculate the content of C13H18ClN3O4S2 taking 585 as the value of A(1%, 1 cm) at the maximum at 273 nm.
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing 7.5 mg of Cyclopenthiazide with 50 mL of methanol for 10 minutes and dilute to 100 mL with methanol. Mix, filter, dilute 20 mL of the filtrate to 100 mL with methanol and measure the absorbance of the resulting solution at the maximum at 273 nm, Appendix II B. Calculate the content of C13H18ClN3O4S2 taking 585 as the value of A(1%, 1 cm) at the maximum at 273 nm.