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Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lignocaine HCl and Nifedipine in Cream

Abstract

A simple, specific, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Nifedipine and Lignocaine HCl In their Combined Dosage Form has been developed. A RP-HPLC method was developed for the simultaneous estimation of Nifedipine and Lignocaine HCl in their Combined Dosage Form has been developed. The separation was achieved by LC- 20 AT C18 (250 mm × 4.6 mm i.d, 5 μm) hypersil BDS column and Buffer (0.05 KH2PO4 pH 3.0): Methanol (50:50) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 234 nm. Retention time of Lignocaine HCl and Nifedipine were found to be 4.170 min and 6.530 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Nifedipine 1.5-4.5 μg/ml and for Lignocaine HCl 7.5-22.5 μg/ml. Developed method was found to be accurate, precise and simple, specific for simultaneous estimation of Nifedipine and Lignocaine HCl in their Combine Dosage Form. The drug was subjected to stress condition of hydrolysis, Oxidation, Photolysis and Thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form.

Tulsi Modi*, Bhumi Patel and Jaimin Patel

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