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Ch. Venkata Kumar , D. Anantaha Kumar , J. V. L. N. Seshagiri Rao

Abstract

A rapid, selective and sensitive high performance liquid chromatographic method for the estimation of Penciclovir in human plasma has been developed. Chromatography was carried out on a Hypersil BDS C₁₈ column using a mixture of 20mM Potassium dihydrogen phosphate buffer (pH 3.5 ± 0.05) and methanol (95:5 v/v) as the mobile phase. The eluents were monitored for the drug by UV detection at 254 nm. Acyclovir was used as an internal standard for this study. The retention times for Penciclovir and Acyclovir were found to be 6.2 and 9.2 min respectively. The method was found to be linear in the concentration range of 50.1 ng/mL to 7000.9 ng/mL. The method was validated as per FDA guidelines and was found to be suitable for bioequivalence and pharmacokinetic studies.

Keywords

Penciclovir, Determination, Plasma, HPLC.

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Gandla. Kumara Swamy ¹, J. M. Rajendra Kumar ², J. V. L. N. Seshagiri Rao ³

Affiliations
1 Department of Pharmaceutical Analysis, Jawaharlal Nehru Technological University, Kakinada, Kakinada - 533 003-Andhra Pradesh, IN
2 Mylan Laboratories Limited, Plot no 31, 32, 33and34-A, Anrich Industrial Estate, Bollaram, Medak(Dist) 502325, IN
3 Srinivasa Rao College of Pharmacy, Pothina Mallayya Palem, Madhurawada, Visakhapatnam -500041 A.P., IN

Abstract

The simple, accurate and precise, isocratic RP-HPLC method has been developed and validated for simultaneous estimation of Clinidipine and Valsartan in bulk and tablets dosage forms. The chromatographic separation was achieved on an Waters symmetry C₁₈ (150x4.6 Id, 3.5μ) with a composition of Acetonitrile : phosphate buffer pH 3.5 adjusted with orthophosphoric acid (70:30, v/v) as mobile phase; at a flow rate of 1.0 ml/min. PDA detection of separtion was performed at 254 nm. The retention times were 2.33 and 3.55 minutes. for Clinidipine and Valsartan respectively. Calibration curves were linear (r²>0.998) over the concentration range 1.2-6.0 μg/ml for Clinidipine and 10-50μg/ml Valsartan. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Clinidipine and Valsartan in bulk drug and tablet dosage form.

Keywords

Clinidipine and Valsartan, RP-HPLC, Tablet Dosage Forms, Forced Degradation Studies.

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P. Nagaraju ¹, Z. Vishnu Vardhan ², J. V. L. N. Seshagiri Rao ³

Affiliations
1 Hindu College of Pharmacy, Amaravathi Road, Guntur-522002 (Andhra Pradesh), IN
2 Department of Environmental Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, IN
3 University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, IN

Abstract

A simple, sensitive and precise reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Atorvastatin calcium and Ezetimibe in pharmaceutical dosage forms. The mobile phase consisted of Acetonitrile: buffer (0.1% v/v ortho phosphoric acid, P^H-6) in the ratio 60:40 delivered at a flow rate of 1 ml/min and wavelength of detection at 232 nm. The retention times of Atorvastatin calcium and Ezetimibe were 3.7 min and 6.1 min respectively. The developed method was validated according to ICH guidelines. The proposed method can be used for determination of these drugs in combined dosage forms.

Keywords

Atorvastatin Calcium, Ezetimibe, RP-HPLC.

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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, 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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