N. Appala Raju

A Validated RP-HPLC Method for the Determination of Atazanavir in Pharmaceutical Dosage Form

A validated RP HPLC method for the estimation of atazanavir in capsule dosage form on YMC ODS 150 × 4.6 mm, 5 μ column using mobile phase composition of ammonium dihydrogen phosphate buffer (pH 2.5) with acetonitrile (55:45 v/v). Flow rate was maintained at 1.5 mL/min with 288 nm UV detection. The retention time obtained for atazanavir was at 4.7 min. The detector response was linear in the concentration range of 30 - 600 μg/mL. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Hence, this method can be applied for routine quality control of atazanavir in capsule dosage forms as well as in bulk drug.

Estimation of Levetiracetam in Tablet Dosage Form by RP-HPLC

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of levetiracetam in tablet dosage form. A Sun Fire C18, 250 x 4.6 mm, 5 μm partical size, with mobile phase consisting of acetonitrile and 0.03 M potassium dihydrogen phosphate (pH adjusted to 3.0 with orthophosphoric acid) in the ratio of 15:85 v/v was used. The flow rate was 1 mL /min and the effluents were monitored at 210 nm. The retention time was 5.53 min. The detector response was linear in the concentration of 20-240 μg/mL. The respective linear regression equation being Y= 22119.684 x 6829.3428. The limit of detection and limit of quantification was 0.16 and 0.5 μg/mL respectively. The percentage assay of levetiracetam was 99.87%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of levetiracetam in bulk drug and in its pharmaceutical dosage form.

RP-HPLC Method for the Estimation of Nelfinavir Mesylate in Tablet Dosage Form

A reverse phase HPLC method is described for the determination of Nelfinavir Mesylate in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 6 (90:10 v/v) as the mobile phase at a flow rate of 1.2 mL/min with detection at 230 nm. The retention time of the drug was 6.68 min. The detector response was linear in the concentration of 1-20 mcg/mL. The limit of detection and limit of quantification was 1.0 and 10.0 mcg/ mL respectively. The percentage assay of Nelfinavir Mesylate was 99.77 %. The method was validated by determining its sensitivity, accuracy and precision. The proposed method is simple, fast, accurate and precise and hence can be applied for routine quality control of Nelfinavir Mesylate in bulk and tablet dosage form.

Spectrophotometric Estimation of Abacavir Sulphate in Pharmaceutical Formulations

Two simple, accurate, rapid and sensitive methods (A and B) have been developed for the estimation of abacavir sulphate in its pharmaceutical dosage form. The method A and B are based on the formation of chloroform extractable complex of abacavir sulphate with bromophenol blue (method A) and bromocresol green (method B), which shows absorbance maxima at 460 nm and 469 nm respectively. The absorbance-concentration plot is linear over the range of 1-10 mcg/mL for method A and B respectively. Results of analysis for all the methods were validated statistically and by recovery studies. The proposed methods are economical and sensitive for the estimation of abacavir sulphate in bulk drug and in its tablet dosage form.

ESTIMATION OF TRIMEBUTINE MALEATE IN TABLET DOSAGE FORM BY RP - HPLC

A simple, precise, rapid and accur a te reverse phase HPLC method was developed for the estimation of Trimebutine Maleate in tablet dosage form. A n XTerra(R) C18 analytical column ( 250 x 4.6 mm , 5 μm partical size ) with mobile phase consisting of mixture of buffer 0.0 2 M Ammonium Acetate in water and acetonitrile in the gradient program was used. The flow rate was 1.0 mL /min and the effluents were monitored at 275 nm . The retention time was 17.0 min utes . The detector response was linear in the concentration of 2 0 - 3 0 0 mc g/ mL . The respective linear regression equation being y = 1914.1 x - 1911 . The limit of detection and limit of quantification was 0. 5 mcg /mL and 1.5 mc g/ mL respectively. The percenta ge ass ay of Trimebutine Maleate was 99. 8 %. The method was validated by determining its accuracy, precision and system suitability . The results of the study showed that the proposed RP - HPLC method is simple, rapid , precise and accurate, which is useful for the routine determination of Trimebutine Maleate in bulk drug and in its pharmaceutical dosage form.

The Estimation of Ceftaroline Fosamil in Lyophillized Powder for Injection by RP-HPLC

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Ceftaroline Fosamil in sterile powder for injection. An RP C-18 Hypersil BDS C18, 150x4.6 mm i.d, 5 µm partical size, with mobile phase consisting of mixture of 0.03 M ammonium acetate in water (solvent A) and methanol (solvent B) was set in the gradient mode over 30 minutes, was found to be most suitable for gradient mode was used to separate ceftaroline fosamil. The flow rate was kept at 1 ml/min and the effluents were monitored at 205 nm. The retention time was 13.12 min. The detector response was linear in the concentration of 20-240 mcg/ml. The respective linear regression equation being Y=25740x+70940. The limit of detection and limit of quantification was 0.25 and 0.75 mcg/ml respectively. The percentage assay of Ceftaroline Fosamil was 99.75%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Ceftaroline Fosamil in bulk drug and in its pharmaceutical dosage form.

ESTIMATION OF ATOSIBAN ACETATE IN PARENTERALS BY RP - HPLC

A simple, precise, rapid and accur a te reverse phase HPLC method was developed for the estimation of Atosiban Acetate in dosage form. A n XTerra MS C18 analytical column ( 250 x 4.6 mm , 5 μm partical size ) with mobile phase consisting of mixture of buffer 0.0 3 M Potassium Dihydrogen Orthophosphate in water and pH adjusted to 3.20 with o rtho - phosphoric acid and acetonitrile in the gradient program was used. The flow rate was 1.0 mL /min an d the effluents were monitored at 2 2 0 nm . The retention time was 1 1.3 min . The detector response was linear in the concentration of 15 - 225 mc g/ mL . The respective linear regression equation being y = 1286.9 x - 1290 . 8 . The limit of detection (LOD) and limit of quantification (LOQ) for Atosiban Acet ate were found to be 1.5 mcg/mL and 4.5 mcg/mL respectively . The percentage ass ay of Atosiban Acetate was 99. 6 %. The method was validated by determining its accuracy, precision and linearity . The results of the stu dy showed that the proposed RP - HPLC method is simple, rapid , precise and accurate, which is useful for the