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PIROXICAM

CHEMICAL NAME & STRUCTURAL FORMULA OF ACTIVE

INGREDIENT

DRUG NAME : Piroxicam

SYNONYM

MOLECULAR FORMULA : C15Hi3N304S

CHEMICAL NAME : 4-hydroxy-2-methyl-N-(2-pyridyl)-2H-1,2-benzothiazine -3-carboxamide-l,l-dioxide

SPECIFICATION OR IPREFERENCE TEXT

C15H13N304S Mol.Wt. 331.35

Piroxicam is 4-hydroxy-2-metfayl-N-(2-pyridyl)-2H-l,2- benzothiazine -3-carboxamide-

1,1- dioxide.

CATEGORY:Analgesic; antiinflammatory; antipyretic.

DOSE :10 to 20 mg daily.

DESCRIPTION :Off-white to light tan or light yellow powder; odourless.

SOLUBILITY:Slightly soluble in ethanol (95%) and in aqueous alkaline solutions; very slightly soluble

in water, in dilute acids and in most organic solvents.

STORAGE:

Store in tightly-closed, light resistant containers .

STANDARDS:Piroxicam contains not less than 97.0 per cent and not more than 103.0 percent

ofC15H13N3O4S, calculated with reference to the anhydrous substance.

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IDENTIFICATION :

A. The infrared absorption spectrum. Appendix 5.4, is concordant with the referencespectrum of piroxicam or with the spectrum obtained from piroxicam RS.

B. The light absorption in the range 230 to 360 nm of a 0.001% w/v Solution in 0.01 Mmethanolic hydrochloric acid exhibits two maxima, at about 242 nm and 334 nm and aminimum at about 270 nm; absorbance at about 334 nm, about 0.87, Appendix 5.5.

C. Carry out the method for thin layer chromatography. Appendix 4.6, using silica gelGF254 as the coating substances and a mixture of 95 volumes of toluene and 5 volumes

of acetic acid as the mobile phase but allowing the solvent front to ascend 15 cm above

the line of application. Apply separately to the plate 20 jul of each of the two solutions in

a mixture of equal volumes of chloroform and methanol containing (1) 0.1 % w/v of thesubstance being examined, (2) 0.1 % w/v of piroxicam RS . Allow it to dry and develop

again. After removal of the plate allow it to dry in air and examine under ultra-violet light

(254 nm). The principal spot in the chromatogram obtained with solution (1) correspondsto that in the chromatogram obtained with solution (2).

HEAVY METALS:Not more than 50 ppm, determined on 0.4 g by Method B, Appendix 3.12.

SULPHATED ASH :Not more than 0.3 %, Appendix 3.22.

WATER:Not more than 0.5 %w/w, determined on 2.0 g, Appendix 3.24.

ASSAY:

Carry out the method for high performance liquid chromatography, Appendix 4.3, using die

following solutions in 0.1 M methanolic hydrochloric acid containing (1) 0.005% w/v of thesubstance being examined and (2) 0.005 % w/v of piroxicam RS.

The Chromatographic procedures may be carried out using (a) a stainless steel column packed

with stationary phase LCI, (b) a degassed mixture of 45 volumes of methanol and 55 volumes ofa buffer solution prepared by diluting a mixture of 7.72 g of anhydrous citric acid in 400 ml of

water and 5.35 g of sodium phosphate in 100 ml of water to 1000 ml with water as the mobile

phase with a flow rate of 1.2 ml per minute and (c) a detection wavelength of about 254 run.

The column efficiency determined using solution (2) is not less than 500 theoretical plates, the

tailing factor is not more than 1.5. The test is not valid unless the relative standard deviation for

replicate injections is not more than 2.0 %. Calculate me content of C15H13N3O4S in piroxicamRS.