Validated Reverse Phase HPLC Method for The Determination of Pemetrexed Disodium in Pharmaceutical Dosage Forms

T. Banu¹, M. B. Varanasi^*, M. M. Ali Khan, J. V. C Sharma, B. Bhanu Teja², V. S. Kumar³ and M. Habibuddin⁴    

¹Department Of Pharmaceutical Analysis, Sultan-Ul-Uloom College Of Pharmacy, Mount Pleasant, Road No.3,Banjara Hills, Hyderabad - 34 India.

²M/s.TherDose Pharma Pvt. Ltd, Pragathi Nagar, IE, Kukatpally,Hyderabad - 500 072 India.

³M/s. Incogen Therapeutics Ltd, ICICI Knowledge Park, Shamirpet, Hyderabad India.

⁴Alliance Institute of Advanced Pharmaceutical and Health Sciences, Aditya Trade Center-604A, Ameerpet, Hyderabad - 500 038 India.

ABSTRACT:

A simple and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for quantitative determination of Pemetrexed Disodium in bulk drug samples and formulations. The method was validated for system suitability, accuracy, precision, linearity, specificity, solution stability, limit of detection and limit of quantitation. Pemetrxed Disodium was analyzed by using Zorbax SB – C18 (250 mm x 4.6 mm, 5 µm) at ambient temperature, with isocratic elution of Buffer:Acetonitrile (90:10). The flow rate was set at 0.9 ml/min and the analysis was performed at a wavelength of 265 nm using Photo Diode Array (PDA) detector. Efficient UV detection at 265 nm enabled determination of Pemetrexed disodium without any interference from injectable solution excipients or solvents. The retention time (RT) for Pemetrexed disodium was around 6 min. The calibration curves were linear over a concentration range from 0.06248 mg to 0.49984 mg/ml. Limit of detection (LOD) for Pemetrexed disodium was 0.00002522 mg/ml and Limit of quantitation (LOQ) was 0.0001261 mg/ml. The developed method was successfully applied to estimate the amount of Pemetrexed disodium in formulations.

KEYWORDS:

Pemetrexed disodium; high performance liquid chromatography; reverse phase liquid chromatography; validation

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Copy the following to cite this article: Banu T, Varanasi M. B, Khan M. M. A, Sharma J. V. C, Teja B. B, Kumar V. S, Habibuddin M. Validated Reverse Phase HPLC Method for The Determination of Pemetrexed Disodium in Pharmaceutical Dosage Forms. Orient J Chem 2010;26(4).

Copy the following to cite this URL: Banu T, Varanasi M. B, Khan M. M. A, Sharma J. V. C, Teja B. B, Kumar V. S, Habibuddin M. Validated Reverse Phase HPLC Method for The Determination of Pemetrexed Disodium in Pharmaceutical Dosage Forms. Orient J Chem 2010;26(4). Available from: http://www.orientjchem.org/?p=23773