Research Journal of Pharmaceutical Dosage Form and Technology

B. Kalyana Ramu ¹, M. Syam Bab ², U. Viplava Prasad ²

Affiliations
1 Department of Chemistry, Maharajah’s College (Aided & Autonomous), Vizianagaram-535002 (AP), IN
2 Department of Organic Chemistry& Analysis of Foods Drugs & Water Laboratories, School of Chemistry, Andhra University, Visakhapatnam- 530003 Andhra Pradesh, IN

Abstract

A Simple, sensitive spectrophotometric method in visible region was developed for the estimation of osetamivir phosphate in bulk and solid dosage forms. The method is based on the ferric hydroxamate reaction purple red colored species is formed with hydroxylamine-ferric per chlorate reagent in non aqueous medium which exhibits maximum absorption at 514 nm. Beer's law obeyed in the concentration range of 20-60μg/ml. commercially available Natflu capsules were analyzed, and the results are statistically compared with those obtained by the UV reference method and validated by recovery studies. The results obtained by the proposed method were in good agreement with the labeled amounts and found satisfactory and reproducible. The method is applied successfully for the estimation of the Oseltamivir phosphate in the presence of other ingredients that are usually present in dosage forms. The method offers the advantages of rapidity, simplicity and sensitivity and normal cost and can be easily applied to resource-poor settings without the need for expensive instrumentation and reagents.

Keywords

Anti Viral, Capsules, Hydroxylamine, Ferric per Chlorate, Regression Equation.

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U. Viplava Prasad ¹, M. Syam Bab ², B. Kalyana Ramu ³

Affiliations
1 Department of Organic Chemistry and Analysis of Foods Drugs and water Laboratories, AU College of Science and Technology, Andhra University, Visakhapatnam -530003 Andhra Pradesh, IN
2 Department of Organic Chemistry, AU College of Science and Technology, Andhra University, Visakhapatnam -530003 Andhra Pradesh, IN
3 Department of Chemistry, Maharajah’s College (Aided and Autonomous), Vizianagaram-535002 (AP), IN

Abstract

Two simple, sensitive and affordable visible spectrophotometric methods (M₁ and M₂) have been developed for the estimation of tolterodine tartrate (TT) in bulk and dosage forms. Method M₁ involves Internal salt formation of aconitic anhydride, dehydration product of citric acid [CIA] with acetic anhydride [Ac2O] to form colored chromogen with an absorption maximum of 565 nm and the method M₂ is based on the formation of green colored coordination complex by the drug with cobalt thiocyanate which is quantitatively extractable into nitro benzene with an absorption maximum of 625 nm. Beer's law obeyed in the concentration range of 8-24μg/ml for method M₁ and 16-48 μg/ml for method M₂. Commercial available capsules were analyzed and the results are statistically compared with those obtained by the reference UV method and validated by recovery studies. The results are found satisfactory and reproducible. These methods are applied successfully for the estimation of the tolterodine tartrate in the presence of other ingredients that are usually present in dosage forms. These methods offer the advantages of rapidity, simplicity and sensitivity and normal cost and can be easily applied to resource-poor settings without the need for expensive instrumentation and reagents.

Keywords

Assay, Acetic Anhydride, Citric Acid, Cobalt Thiocyanate, Beer’s Law, Nitro Benzene, Capsules.

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U. Viplava Prasad ¹, M. Syam Bab ¹, B. Kalyana Ramu ²

Affiliations
1 Department of Organic Chemistry and Analysis of Foods Drugs and Water Laboratories, School of Chemistry, Andhra University, Visakhapatnam-530003, Andhra Pradesh, IN
2 Department of Chemistry, Maharajah’s College (Aided & Autonomous), Vizianagaram-535002 (AP), IN

Abstract

The drug Sapropterin (SAP) dihydrochloride is an enzyme cofactor and oral form of a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin(BH₄) and used to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA). Purpose: The aim of the present investigation was to see the simple and sensitive visible spectrophotometric methods for the determination of the sapropterin dihydrochloride in bulk and tablet dosage forms. Methods: Two simple, sensitive and cost effective visible spectrophotometric methods (M₁-M₂) were developed for the estimation of sapropterin dihydrochloride in bulk and dosage forms. The first method (M₁) is based on the formation of blue reduced product by treating drug with Folin Ciocalteu (FC) reagent in the presence of sodium carbonate solution with an absorption maximum of 770nm. The second method (M₂) is based on the reaction of drug with ferric chloride and potassium ferricyanide to form a dark green colored species having absorption maxima at 704nm. Results: Beer's law obeyed in the concentration range of 2-6 μg/ml and 2.5-12.5 μg/ml for method M₁ and M₂ respectively. No interference was observed from the usually existing additives in pharmaceutical formulations and the applicability of the methods was examined by analyzing kuvan tablets containing SAP. Conclusion: The reported methods HPLC for its assay involve sophisticated equipment, which are very costly and pose problems of maintenance. To overcome these problems, the use of visible spectrophotometric technique is justifiable. The statistical data proved the accuracy, reproducibility and the precision of the proposed methods.

Keywords

Assay, FC Reagent, Ferric Chloride, Potassium Ferricyanide, Redox Reaction, Kuvan Tablets.

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