Thursday, February 28, 2013

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Tuesday, February 26, 2013

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Monday, February 25, 2013

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Sunday, February 24, 2013

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Thursday, February 21, 2013

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Tuesday, February 19, 2013

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Wednesday, February 13, 2013

Assay Method (U-Z)



Assay Method of
 Ursodeoxycholic Acid Tablet

Sample 
Take average weight of 20 tablet and crush in a mortar to achieve fine powder. Take equivalent amount of tablet powder containing 150 mg of Ursodeoxycholic Acid in 50 ml Ethanol R into 250ml titration vessel, previously neutralized to 0.2 ml of phenolphthalein solution R. Add 50 ml of Distilled Water and Titrate with 0.1M Sodium Hydroxide VS until a pink color is obtained.
Each ml of 0.1M Sodium Hydroxide VS is equivalent to 39.26 mg of Ursodeoxycholic Acid.

  Assay Method of
 Valdicoxib Tablet

Buffer
Dissolve about 3.854 g of Ammonium Acetate in 900 ml water. Adjust pH to 5.0±0.05 with dilute acetic acid and dilute to 1000 ml with water.
Ratio   
Mix 50 volume of Buffer with 50 volume of methanol and filter through a 0.45-micron membrane filter and degas.
Standard 
Dissolve about 25.0 mg of valdicoxib WS in 50 ml of methanol and dilute to 100 ml with water. Dilute 5 ml to 50 ml with mobile phase. Filter this solution with 0.45 m membrane filter before injection.
Sample 
Shake a quantity of the powdered sample containing about 25.0 mg of Valdicoxib in 50 ml of methanol for 30 minutes, dilute to 100 ml with water and then filter. Dilute 5 ml of filtrate to 50 ml with mobile phase. Filter this solution with 0.45 m membrane filter before injection.
Condition
C18 Column (4.6 mmx 25cm) & 10µm (ODS1)./ UV at 245 nm

Assay Method of
 Valproic acid + Sodium Valproate Tablet

For Valproic Acid
Sample 
Weigh & take the average weight of 20 tablets. Crush the tablets into fine powder. Take a quantity of the powder containing equivalent to 58 mg of Valproic acid into a 200 ml volumetric flask. Add accurately 100 ml of ethanol 96%. Shake for 20 minutes & filter. Take 50 ml of filtrate solution in 100 ml conical flask & add 1 ml of 1% Phenaphaline solution as indicator. Titrate with 0.1M Sodium hydroxide VS to a pink color end point. Perform blank titration for necessary correction.
Each ml of 0.1M Sodium hydroxide VS  º 14.42 mg of Valproic Acid
 \ Content of Sodium valproate (C1) in mg º  ( 87 x % of Valproic acid ) x 1.1517           

For Sodium Valproate
Sample 
Weigh & take the average weight of 20 tablets. Crush the tablets into fine powder. Take a quantity of the powder containing equivalent to 66.8 mg of Sodium valproate into a 100 ml glass vessel. Add 60 ml of glacial acetic acid & shake for 20 minutes. Titrate with 0.1M Perchloric Acid vs using     crystal violet solution as indicator. Perform blank titration for necessary correction.
Each ml of 0.1M Perchloric Acid VS  º 16.62 mg of Sodium valproate.
                                              
Assay Method of
 Verapamil Hydrochloride Tablet
                             .
Sample 
Shake a quantity of the powder containing 100 mg of Verapamil Hydrochloride
with 150 ml  of  0.1 M  hydrochloric  acid for 10 minutes;  add sufficient 0.1 M
hydrochloric acid to produce 200 ml and filter. Dilute 10 ml of the filtrate to 100
ml with water.Measure the absorbance of the resulting solution at the maximum
at 278 nm using 0.1 M hydrochloric acid as blank.
Calculation
 % of Verapamil Hydrochloride=Absorbance of Sample´100/Conc. Of spl.´118                                               

Assay Method of
 Vinpocetine Tablet

Solvent
Chloroform
Standard 
50 mg ----® 100 ml ----® take 5 ml ----® 50 ml  (Shake 20 minutes)
Sample 
Same as standard. Take absorbance at 336 nm.

Assay Method of
 Zinc (Elemental) Syrup

Sample 
Take 35 ml of Nid Syrup equivalent to about 70 mg of Elemental Zinc (35ml) in a 250 ml conical flask. Add 100 ml distilled water & mix well. Then add 5 ml of Ammonia - Ammonium Chloride buffer TS and using 0.1 ml of Erio-Chrome Black TS as   indicator. Titrate immediately with 0.05M Na2EDTA VS. At the end point the solution become violet to deep blue. Each ml of 0.05M Na2EDTA VS is equivalent to 3.269 mg of elemental Zinc.

% of Zinc =    Required Vol. Of VS x Constant x F x 100 / Weight of Elemental Zinc in sample Solution

Assay Method (T)



Assay Method of
 Tamsulosin Hydrochloride Tablet

Buffer

Take 1.25 gm Di-Sodium hydrogen orthophosphate & 0.125 gm Potassium di-hydrogen orthophosphate in 500ml of water & adjust the PH to 4.0 with dilute phosphoric acid.  Filter through 0.45 m membrane filter and Degasses.  
Ratio   
Methanol : Buffer = 60 : 40
Diluents
Methanol 
Standard 
Accurately weigh and transfer about 20 mg Tamsulosin HCl Working Standard in a 100-ml Volumetric flask. Add Diluents and shake for10 minutes and make the volume up to mark & mix well. Transfer 4 ml of this solution in a 100 ml volumetric flask and add diluents up to the  mark (100 ml) & mix well. Filter this solution with 0.45m membrane filters before injection 
Sample 
Weigh and powder 20 tablets. Take powder-containing equivalent to 0.4 mg of Tamsulosin HCl in a 50-ml volumetric flask. Add Diluents (Methanol HPLC grade) and shake for 30 minutes & degasses for 10 minutes and make the volume up to mark & mix well. Filter the solution  through whatman filter paper no.1 and half of   Filter this solution with 0.45m  membrane filters before injection 
Condition
Waters Spherisorb 10.0 mm ODS2   4.6 ´ 250mm./ UV at 225 nm / 15 minutes.

Assay Method of
 Telmesartan INN Tablet

Buffer
pH 3.5
Dissolve 3.4 gm Potassium Dihydrogen Phosphate in 1000 mL of water. Add 1.0 mL of Triethylamine and adjust
pH to 3.5 with dilute ortho Phosphoric acid.
Ratio
Buffer 60 % : Acetonitryl 40 %
Diluents
Methanol
Standard 
Weigh accurately about 50 mg Telmisartan WS and transfer it in a 100 ml volumetric flask. Add 50 ml of Methanol. Shake for 10 min. Then add sufficient Methanol to make 100 ml. Mix and filter this solution with 0.45mm membrane filter before injection.
Sample 
Take 20 tablets, weigh and determine the Average weight. Then crush these tablets into fine powder using mortar and pastle. Take accurately weight of the Tablet powdered sample containing about 50 mg Telmisartan and transfer in a 100 ml volumetric flask. Add 60ml of Methanol. Shake for 20 min and add sufficient diluent to make 100 ml. Mix well and degassed for 10 minutes. Then filter the solution with whatman filter paper. Filter this resultant solution with 0.45 mm membrane filter before injection.
Condition
Luna C18 5µm. 4.6 × 250mm. / 230 nm / 1ml per minute / 20 mL / 25 minutes / 19 minutes (Approx.)

Assay Method of 
 Tenoxicam Tablet

Sample
Take powdered sample equivalent to 90 mg of Tenoxicam and dissolve in a mixture of 70 ml Glacial Acetic Acid and 5 ml of Formic Acid solution which is previously neutralized. Titrate with 0.1 N Perchloric acid and determine the end point potentiometrically using crystal violet as an indicator. 1 ml 0.1N Perchloric acid VS ≡ 33.74 mg of Tenoxicam

  Assay Method of
 Terbinafine Hydrochloride Tablet

Solvent
Methanol
Standard 
50 mg ---® 100 ml ---® take 1 ml ---® 50 ml ---® take 5 ml ---® 50 ml
Sample 
Same as Standard. Take absorbance at 223 nanometer.

Assay Method of
 Tetracycline Capsule

Sample 
Weigh and powder 20 capsules. Take powder  equivalent to  50 mg of Tetracycline Hydrochloride  in 100 ml volumetric flask. Add 60 ml of 0.1N Hydrochloric acid  and shake for 20 minutes. Make the volume up to 100 ml with the same solvent . Mix and filter. Dilute 1 ml of the filtrate to 50 ml with  0.1N Hydrochloric acid . Measure absorbance at 274 nm , taking 0.1N Hydrochloric acid  as Blank .
% of content  =  Absorbance  x 100 / conc. in g /100 ml x 387

Assay Method of
 Tiemoniun methylsulphate Tablet

Buffer
Add 1 ml triethylamine in 500 ml of water and adjust the PH  3.0( ±0.05) with dilute phosphoric acid.
Ratio   
Acetonitrile : Buffer in the proportion of  70 : 30
Diluents
Acetonitrile : Buffer in the proportion of  70 : 30
Standard 
Accurately  weigh and  transfer about 25 mg of Tiemoniun methylsulphate   working  standard  in a 100 ml volumetric flask .Add 70 ml diluents and shake for 10 minutes and make the volume up to the mark with the same solvent. Filter this solution with 0.20 m membrane filter before injection.  
Sample 
Weigh and make fine powder of  20 tablets. Take an accurately weighed portion of powder equivalent to 25 mg of Tiemoniun methylsulphate in a 100 ml volumetric flask. Add 70 ml of diluents and shake for 10 minutes . Adjust the volume to100 ml with the same solvent .Then degassed it for 15 minutes. Filter the solution by Whatman filter paper. Further  filter this solution with 0.20 m membrane filter before injection.  
Condition
XTerra® RP18 ,5 mm    4.6 ´ 250mm./ UV at 235 nm / 8 minutes

Assay Method of
 Tiemoniun methylsulphate Injection

Solvent
water
Standard 
50 mg ---® 100 ml ---® take 5 ml ---® 100 ml (Shake 20 minutes)
Sample 
Same as Standard. Take absorbance at 235 nanometer.
                                                                 
Assay Method of
 Tizanidine Tablet

Buffer
Dissolve 6.8 gm Monobasic potassium phosphate[ KH 2  PO4 ]in 500 ml of water and make up to 1000 ml with  water. Adjust pH of this solution to 7.5 ± 0.1with potassium hydroxide.
Ratio   
Accetonitrile : Buffer º 50 : 50
Diluents
Accetonitrile : Buffer º 20 : 80
Standard 
Weight and transfer about 25 mg working standard of Tizanidine in a 100 ml  volumetric flask. Add 70 ml of solvent and shake for 20 minutes and dilute with solvent up to the mark and mix well. Take 5 ml solution in a 50 ml volumetric flask and dilute with solvent and mix well.Filter this solution with 0.45 m membrane filter before injection.
Sample 
Take the weight of 20 tablets & determine the average weight. Crush the tablets into fine powder. Take an amount of powder sample equivalent to  25 mg Tizanidine in a 100 ml volumetric flask. Add 70 ml solvent and shake for 30 minutes and  dilute  with solvent up to the mark and mix well. Filter the solution by whatman filter paper and take 5 ml solution in a 50 ml volumetric flask and dilute with solvent and mix well. Finally filter this solution with 0.45 m  membrane filter before injection.
Condition
XTerra RP18 , 5 mm  4.6 ´ 250mm./ 40°C  / UV at 230 nm / 8 minutes.

Assay Method of 
 Theophylline Tablet & Syrup

Buffer
Transfer 1.36 gm of Sodium acetate trihydrate to a 1000 ml volumetric flask add about 200 ml of distilled water and shake until dissolution is complete and volume up to 1000 ml with distilled water .
Ratio   
Mix buffer solution and acetonitrile  (70 : 30 ) filter through 0.45 m  membrane filter and degasses.
Diluents
Mobile Phase
Standard 
Weight and transfer about 50 mg working standard of Theophylline  in a 50 ml volumetric flask. Add 30 ml of Mobile Phase and shake for 20 minutes and dilute with  Mobile Phase up to the mark and mix well. Take 5 ml solution in a 50 ml volumetric flask and up to the mark with Mobile Phase and mix well. Filter this  solution with 0.45 m membrane filter before injection.
Sample 
Take the weight of 20 tablets & determine the average weight. Crush the tablets into fine powder. Take an amount of powder sample equivalent to  50 mg Theophylline in a 50 ml volumetric flask. Add 30 ml Mobile Phase and shake for 30 minutes and  dilute  with Mobile Phase up to the mark and mix well. Filter the solution by whatman filter paper and take 5 ml filtrate solution in a 50 ml volumetric flask and up to the mark with Mobile Phase and mix well. Finally filter this solution with 0.45 m  membrane filter before injection.
Condition
Waters Sphreisorb  ODS1 , 10 m  250 x 4.6 mm./ 40°C  / UV at 280 nm / Theophylline  = 3.5 minutes.

Assay Method of 
 Tolperiaone Hydrochloride Tablet

Sample
Dissolve powdered sample equivalent to 100 mg Tolperiaone Hydrochloride in previously neutralized mixture of 60 ml glacial acetic acid and acetic anhydride (40 ml + 20 ml) using crystal violet solution as indicator. Titrate with 0.1 M perchloric acid and determine the end point.Each ml of 0.1M perchloric acid VS is equivalent to 28.183 mg of Tolperiaone Hydrochloride.% of content =   V x F x 28.183 x 100 / W

Assay Method of 
 Tramadol Hydrochloride Suppository


Sample 
Weigh 20 Suppositories and then cut in to small pieces. Take about 1.4 gm sample equivalent to 100 mg Tramadol Hydrochloride in a warm mixture of 25 ml Glacial Acetic Acid, 10 ml Acetic Anhydride and carryout non aqueous titration, determining the end point Potentiometrically. Perform a reagent blank use Crystal violet indicator if necessary.
Each ml of 0.1 M Perchloric acid VS is equivalent to 29.98 mg of Tramadol Hydrochloride

Assay Method of
 Tramadol Hydrochloride Capsule & Injection


Solvent
Water
Standard 
50 mg ----® 100 ml ----® take 10 ml ----® 50 ml  (Shake 15 minutes)
Sample 
Same as standard. Take absorbance at 272 nm.

Assay Method of
 Trimetazidine Dihydrochloride Tablet

Buffer
Take 6.805  gm & Potassium Dihydrogen Phosphate in a 1000ml volumetric flask and adjust the volume with Distilled water & adjust the pH 4.5 with Phosphoric Acid.
Ratio   
ACN : Buffer = 40: 60  
Standard 
Accurately weigh and transfer about 25 mg of working standard of Trimetazidine.Dihydrochloride  into 50 ml volumetric flask Add 35 ml of Methanol  & shake for 20 minutes and  dilute with Methanol up to the mark and then sonicate for 20  minutes Take 2 ml of the solution in a 50 ml volumetric flask. Volume up  to mark with Methanol .Filter this solution with 0.25 m membrane filter before injection.
Sample 
Weigh of 10 tablets and make it  powder. Take powder-containing equivalent to 25 mg of Trimetazidine Dihydrochloride in a  50-ml volumetric flask. Add 35 ml of Methanol & shake for 20 minutes. Dilute with Methanol up to the mark then  Sonicate this Solution for 20   minutes & filter with Whitman filter paper .Take 2 ml of the solution in a 50 ml volumetric flask. Make the volume up  to mark with Methanol. Filter this solution with 0.25 mm
membrane filter before injection.                                           
Condition
Waters Spherisorb 10 mm ODS1  4.6 ´ 250mm./ 40º C / UV at 210 nm / 10 minutes.

Assay Method (S)

Assay Method of
 Salbutamol  Syrup

Reagent 
1. 1M Sodium carbonate solution in water 2. 0.2 % w/v P- aminophenol in ethanol
Standard 
Take Salbutamol sulphate equivalent to 100 mg of salbutamol in a 100 ml volumetric flask. Add 60 ml of water and shake to dissolve .  Dilute to 100 ml with water. Dilute 2 ml  of the resulting solution to 25 ml with water.
Concentration 0.008 %
Sample 
Take 20 ml of syrup equivalent to 8 mg of  Salbutamol in a  100 ml volumetric flask. Dilute with water  to volume and mix. 1 mg  of Salbutamol  equivalent to 1.2049 mg of Salbutamol sulphate
System
Take 3 ml of  sample and standard solution each in two separate 25 ml of volumetric flask. Add 3 ml of  1M sodium carbonate solution and 0.2 ml of P-aminophenol solution to each flask. Dilute to 10 ml with water. Keep at rest for 25 minutes. Measure the absorbance at 635 nm taking water as blank.

Assay Method of
 Sertraline HCl Tablet

Sample 
Take the weigh of   20 tablets & determine the average weight. Then crush them into fine powder. Take powdered sample equivalent to 100 mg of Sertraline Hydrochloride and dissolve in 30 ml Glacial Acetic Acid. Add 10 ml of 6% Mercuric Acetate solution. Carry out a potentiometric titration with 0.1 N Perchloric acid to determine the end point using α-napthyl benzene as an indicator. Perform blank titration If necessary.
1 ml 0.1N Perchloric acid VS ≡ 34.27 mg of Sertraline HCl
Result
Calculation : % of Sertraline   = V x f x C x 100 / W

Assay Method of
 Sildenafil Citrate Tablet

Method – 01/HPLC
Buffer

2.720 gm of Potashium Di Hydrogen Phosphate in 1000 ml volumetric Flask with distilled water, adjust pH 6.5 ± 0.5 with 2N Sodium Hydroxide. filter & sonicate this buffer solution.
Mobile Phase

70% Methanol : 30% Buffer
Diluent  
Methanol
Standard 
10 mg ---® 100 ml
Sample 
10 mg ---® 100 ml
Condition
XTerra Column 4.6 x 250 mm / 400 C/ 292 nm / 1 ml per minute / 10 micro liter / 6 minutes approx

Method – 02/UV
Solvent
Method - 01
Standard 
10 mg ---® 100 ml ---® take 10 ml ---® 50 ml (Shake 10 minutes)
Sample 
Same as Standard. Take absorbance at 292 nanometer.

Assay Method of
 Silver Sulphadiazine Cream

Ratio   
Water : Acetonitrile  : Phosphoric Acid  : : 90 : 9.9 : 0.1
Diluent  
Transfer 100 ml of Ammonia solution (25% concentrate) to a 1 liter volumetric flask & dilute with water to volume & mix.
Standard 
Weigh and transfer about 25 mg  working standard of Silver Sulphadiazine into a 50 ml volumetric flask.Add 30 ml solvent & shake for 20 minutes and dilute to 50 ml with the same solvent and mix well. Transfer 5 ml of this solution in a 50 ml volumetric flask & volume with solvent up to the mark & mix well.  Filter this  solution with 0.45 mic membrane filter before injection.
Sample 
Transfer an accurately weighed quantity of Neozine Cream equivalent to 25 mg of Silver Sulphadiazin in a separating funnel. Add 50 ml of solvent & shake for 10 minutes. Then add 50 ml of chloroform in to the separating funnel & shake for another 10 minutes. Wait for 30 minutes to separate the layer completely, discard the lower layer & collect the upper layer into a 250 ml stopper conical flask & evaporate to remove the chloroform. Cool the solution & transfer it into a 50 ml volumetric flask & volume it with the same solvent. Transfer 5 ml the solution into 50 ml volumetric flask & dilute with the solvent up to the mark. Then filter the this solution with whatmann filter paper & finally filter this solution with 0.45 m m  membrane filter before injection.
Condition
ODS2, 10mm  4.6 x 250 mm / 254 nm / 10 minutes / 7 minutes (approximately)
                                                                                                           
Assay Method of
Simethicon Solution & Tablet

Standard
Take 134 mg of Simethicone Compound in a 50 ml volumetric flask. Add 30 ml of 1 M Sodium Hydroxide and shake for 10 minutes and dilute with 1 M Sodium Hydroxide up to the mark Add this solution into the separating funnel which is pre-washed with 15 ml of 1 M Sodium Hydroxide after adding 67 ml of toluene. Shake this solution for 5 minutes. Allow the mixture to stand for 20 minutes, centrifuge the upper layer and dry with anhydrous sodium sulphate. Measure the absorbance of Simethicone at 1261 cm-1 By  IR Machine.
Sample
Accurately take 2 ml of Flatulex Drops equivalent to 134 mg Simethicone into a 50 ml volumetric flask. Add 30 ml of 1 M Sodium Hydroxide and shake for 10 minutes and dilute with 1 M Sodium Hydroxide up to the mark Add this solution into the separating funnel which is pre-washed with 15 ml of 1 M Sodium Hydroxide after adding 67 ml of toluene. Shake this solution for 5 minutes. Allow the mixture to stand for 20 minutes, centrifuge the upper layer and dry with anhydrous sodium sulphate. Measure the absorbance of Simethicone at 1261 cm-1 By  IR Machine.
        
Assay Method of
 Sulphamethoxazole + Trimethoprim Syrup

Sulphamethoxazole
Dissolve suspension equivalent to 200 mg of Sulphamethoxazole in 60 ml of water and 10 ml of hydrochloric acid. Add 3 g of potassium bromide, cool in ice and titrate slowly with 0.1M Sodium Nitrite VS, stirring constantly and determine the end point electrochemically. Each ml of 0.1M Sodium Nitrite VS is equivalent to 25.33 mg of Sulphamethoxazole.

% of SMZ = No. of ml of VS x F x 25.33 X 100 / Amount of Sulphamethoxazole taken
Trimethoprim
Method I :
To a amount of suspension  containing 50 mg of Trimethoprim add 30 ml of 0.1M Sodium Hydroxide and extract with  two 50 ml quantities of  chloroform, washing each extract with the same two 10 ml quantities of 0.1M Sodium Hydroxide. Combine the chloroform extracts and extract with three 50 ml quantities of  1M Acetic Acid. Dilute the aqueous extracts to 250 ml with 1M Acetic Acid. To 10 ml of the resulting solution add 10 ml of 1M Acetic Acid and sufficient water to produce 100 ml .Measure the absorbance of the resulting solution at the maximum at 271 nm , taking water as blank.Calculate  the content of Trimethoprim  taking 204 as the value of A ( 1%, 1 cm ) at maximum at 271 nm.

% of Trimethoprim  = Absorbance     x   100 / conc. In gm per 100 ml  x  204

Method II :
Take  sample equivalent to 80 mg of Trimethoprim  in a 250 ml separating funnel. Add 30ml of 0.1N sodium hydroxide. Extract two times, each time with 50ml of chloroform. Wash the total extract with 20 ml of water. Collect the extracts in a 400 ml beaker and evaporate the extracts to dryness on a water bath. Dissolve the residue in 30 ml of anhydrous glacial acetic acid. Titrate with 0.1N perchloric acid VS using  naptholbenzein solution as indicator. 1 ml of 0.1N perchloric acid VS   is º 29.03 mg of  Trimethoprim.

% of content  =   No. of ml of VS x F x 29.03 x 100 / Amount of Trimethoprim taken