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Application of RP-HPLC Technique for Development of Analytical Method for Validation of Albuterol Sulphate from Bulk Drug and Dosage Form


Affiliations
1 Central Research Laboratory, D. G. Ruparel College, Matunga, Mumbai 400016 ., Qatar
2 Central Research Laboratory, D. G. Ruparel College, Matunga, Mumbai 400016., India
     

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A novel reverse phase liquid chromatographic method was developed and validated for estimation of Albuterol sulphate in its dosage form i.e. tablets. The reverse phase HPLC analysis was carried out on isocratic system. The column was Hypersil BDS C18 (150mm x 4.6mm, 5µm) with ambient temperature. The mobile phase consisted of buffer: methanol in proportion 75:25 % (v/v). The flow rate was maintained at 1.0ml/min. The detection was carried out at wavelength 225nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy and precision. The linear ranges were 50-150µg/ml for albuterol sulphate, . The accuracy and precision were found to be well within the acceptable limit. The method was successfully applied for determination albuterol sulphate in dosage form with good recoveries.

Keywords

Albuterol sulphate, Tri ethyl amine, Phosphoric acid, Methanol, HPLC
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  • Application of RP-HPLC Technique for Development of Analytical Method for Validation of Albuterol Sulphate from Bulk Drug and Dosage Form

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Authors

Rajan V. Rele
Central Research Laboratory, D. G. Ruparel College, Matunga, Mumbai 400016 ., Qatar
Pratamesh P. Tiwatane
Central Research Laboratory, D. G. Ruparel College, Matunga, Mumbai 400016., India
Sandip P. Patil
Central Research Laboratory, D. G. Ruparel College, Matunga, Mumbai 400016., India

Abstract


A novel reverse phase liquid chromatographic method was developed and validated for estimation of Albuterol sulphate in its dosage form i.e. tablets. The reverse phase HPLC analysis was carried out on isocratic system. The column was Hypersil BDS C18 (150mm x 4.6mm, 5µm) with ambient temperature. The mobile phase consisted of buffer: methanol in proportion 75:25 % (v/v). The flow rate was maintained at 1.0ml/min. The detection was carried out at wavelength 225nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy and precision. The linear ranges were 50-150µg/ml for albuterol sulphate, . The accuracy and precision were found to be well within the acceptable limit. The method was successfully applied for determination albuterol sulphate in dosage form with good recoveries.

Keywords


Albuterol sulphate, Tri ethyl amine, Phosphoric acid, Methanol, HPLC

References