Sat, 18 Nov 2017

Development and Validation of a Novel Ultra Performance Liquid Chromatography Method for Dissolution of Paricalcitol in Paricalcitol Soft Gelatin Capsules

Bhaskara P.V Mantena1,*, Sumathi V Rao1, K.M.Ch. Appa Rao2, K.Ramakrishna2, Jayant Karajgi1, Srikanth Reddy. R1

1.Aurobindo Pharma Limited (A division of APL Research centre), Survey No. 313, Bachupally, Quthubullapur Mandal, Ranga reddy District, Hyderabad-500072, Andhra Pradesh, India.

2.GITAM University, Gandhi Nagar, Rushikonda, Visakhapatnam-530 045. Andhra Pradesh, India


ABSTRACT

A new gradient reverse phase Ultra Performance Liquid Chromatography (UPLC) method was developed for the analysis of Dissolution profile samples of Paricalcitol in Paricalcitol Soft Gelatin capsules. The aim of the new method was to achieve proper accuracy and precision for the highly potent low dose drug product formulations. The normal injection loop allows upto 10µL of the sample in normal condition in UPLC systems.  For the current method the loop was modified to handle 50µL of injection volume in order to achieve quantifiable area counts. Efficient separation is achieved on Acquity UPLC HSS T3 (100 mm length × 2.1 mm ID with, 1.8 m particle size. Validation parameters such as specificity, linearity, precision, accuracy, and robustness were evaluated as per ICH guidelines. The validated RP-UPLC method was successfully applied to the Dissolution of Paricalcitol Soft Gelatin Capsules dosage forms.

Keywords: Paricalcitol, Soft Gelatin Capsules, Validation, Acquity UPLC, 50µL injector loop, dissolution profile tests


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