Informatics Publishing Limited

V. Kiran Kumar ¹, N. Appala Raju ², Namratha Rani ², J. V. L. N. Seshagiri Rao ³, T. Satyanarayana ²

Affiliations
1 Dept. of Pharma. Chem., Sree Chaitanya Institute of Pharmaceutical Sciences, LMD Colony, Karimnagar-505527, A.P., IN
2 Dept. of Pharma. Chem., Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant, Road#3, Banjara Hills, Hyderabad-500034, IN
3 University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, A.P., IN

Abstract

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Irinotecan HCl in tablet dosage form. A X-Terra RP C18, 250×4.6 mm i.d, 5 μm partical size, with mobile phase consisting of Methanol and 0.01 M Ammonium Acetate containing 0.1% formic acid and methanol in the ratio of 50:50 v/v was used. The flow rate was 1 ml/min and the effluents were monitored at 250 nm. The retention time was 4.69 min. The detector response was linear in the concentration of 120-360 mcg/ml. The respective linear regression equation being Y=166582.24x+86439.5. The limit of detection and limit of quantification was 0.06 and 0.18 mcg/ml respectively. The percentage assay of Irinotecan HCl was 99.09%. 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 Irinotecan HCl in bulk drug and in its pharmaceutical dosage form.

Keywords

Irinotecan HCl, RP-HPLC, Estimation, and Tablets.

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V. Kiran Kumar ¹, N. Appala Raju ², Namratha Rani ², J. V. L. N. Seshagiri Rao ³, T. Satyanarayana ²

Affiliations
1 Dept. of Pharma. Chem., Sree Chaitanya Institute of Pharmaceutical Sciences, LMD Colony, Karimnagar-505527, AP, IN
2 Dept. of Pharma. Chem., Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant, Road 3, Banjara Hills, Hyderabad-500034, IN
3 University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, AP, IN

Abstract

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Paclitaxel in Parenterals dosage form. A Unison US C18, 250×4.6 mm i.d, 5 μm partical size, with mobile phase consisting of Methanol and 0.02 M potassium dihydrogen phosphate in water (pH 2.5 adjusted with o-phosphoric acid) in the ratio of 80:20 v/v was used. The flow rate was 1 ml/min and the effluents were monitored at 225 nm. The retention time was 4.978 min. The detector response was linear in the concentration of 15-180 mcg/ml. The respective linear regression equation being Y=46411.83x+29.2578. The limit of detection and limit of quantification was 0.03 and 0.09 mcg/ml respectively. The percentage assay of Paclitaxel was 99.09%. 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 Paclitaxel in bulk drug and in its pharmaceutical dosage form.

Keywords

Paclitaxel, RP-HPLC, Estimation, and Parenteral.

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