Sodium Picosulfate Oral Solution

Sodium Picosulfate Elixir

Stimulant laxative.

Sodium Picosulfate Oral Solution is a solution of Sodium Picosulfate in a suitable flavoured vehicle.

The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.

95.0  to 105.0% of the stated amount.

A.  In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to sodium picosulfate in the chromatogram obtained with solution (2).

B.  Carry out the method for thin-layer chromatography, Appendix III A, using a TLC silica gel F₂₅₄ plate (Merck HPTLC plates are suitable) and a mixture of 2.5 volumes of anhydrous formic acid, 12.5 volumes of water, 25 volumes of methanol and 60 volumes of ethyl acetate as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) dilute, if necessary, a volume of the oral solution with sufficient methanol to produce a solution containing 0.1% w/v of Sodium Picosulfate. Solution (2) contains 0.1% w/v of sodium picosulfate BPCRS in methanol. Dry the plate in a current of hot air for 15 minutes and examine under ultraviolet light (254 nm). Spray with a 20% w/v solution of hydrochloric acid in methanol and heat at 110° for 10 minutes. Spray the hot plate with a freshly prepared solution containing 5% w/v of iron(iii) chloride and 0.1% w/v of potassium hexacyanoferrate(iii) and examine the wet plate in daylight. By each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds to the principal spot in the chromatogram obtained with solution (2).

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute, if necessary, a volume of the oral solution with sufficient water to produce a solution containing 0.005% w/v of Sodium Picosulfate. Solution (2) contains 0.0001% w/v of sodium picosulfate BPCRS. For solution (3) dissolve 10 mg of sodium picosulfate BPCRS in 2 ml of 0.1m hydrochloric acid, bring rapidly to the boil and heat for 1 minute. Cool in ice-water, add 2 ml of 0.1m sodium hydroxide and dilute to 10 ml with the mobile phase. Dilute 2 volumes to 50 volumes with the mobile phase.

The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (5 µm) (YMC Basic is suitable), (b) as the mobile phase with a flow rate of 2 ml per minute a mixture of 620 volumes of a buffer solution containing 3.0 g of disodium hydrogen orthophosphate and 0.5 g of cetyltrimethylammonium bromide in 1000 ml of water, adjusting the pH to 5.0 with orthophosphoric acid, and 380 volumes of acetonitrile and (c) a detection wavelength of 263 nm.

Inject 50 µl of each solution. The test is not valid unless the chromatogram obtained with solution (3) closely resembles the appropriate reference chromatogram supplied with sodium picosulfate BPCRS.

In the chromatogram obtained with solution (1) the area of any peak due to impurity A (4-[(pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl sodium sulphate) is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2.0%).

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute, if necessary, a volume of the oral solution with sufficient water to produce a solution containing 0.005% w/v of Sodium Picosulfate. Solution (2) contains 0.005% w/v of sodium picosulfate BPCRS.

The chromatographic procedure described under Related substances may be used.

Calculate the content of C₁₈H₁₃NNa₂O₈S₂ in the oral solution from the chromatograms obtained and from the declared content of C₁₈H₁₃NNa₂O₈S₂ in sodium picosulfate BPCRS.

Sodium Picosulfate Oral Solution should be protected from light.

When sodium picosulphate oral solution is prescribed or demanded, Sodium Picosulfate Oral Solution shall be dispensed or supplied.

The impurity limited by this monograph is:

A.  4-[(pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl sodium sulphate