Volume : 12, Issue : 11, November – 2025
Title:
METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LIDOCAINE AND PRILOCAINE IN BULK AND PHARMACEUTICAL DOSAGE FROM BY RP-HPLC
Authors :
Gollu vamsi krishna, Dr. P. V. Madhavi latha, Dr. P. Uma devi , k.Suvarna
Abstract :
A simple, precise, and robust RP-HPLC method was developed and validated for the simultaneous estimation of Lidocaine and Prilocaine in pharmaceutical formulations. Chromatographic separation was achieved using a UV detection wavelength of 252 nm, providing well-resolved peaks with retention times of 3.046 min for Lidocaine and 4.312 min for Prilocaine. The method showed excellent system performance, reflected by high USP plate counts (Lidocaine: 21085, Prilocaine: 8359) and low %RSD values in system precision (≤ 0.114%), method precision (≤ 0.108%), and intermediate precision (≤ 0.071%), confirming reproducibility.
The sensitivity of the method was demonstrated by low LOD values (0.074 μg/mL for Lidocaine, 0.175 μg/mL for Prilocaine) and LOQ values (0.225 μg/mL and 0.531 μg/mL, respectively). Linearity was observed in the range of 20–80 μg/mL for both drugs with excellent correlation coefficients (R² = 0.9999). Regression equations confirmed strong linear relationships: Lidocaine (y = 7446.1x – 283.33) and Prilocaine (y = 39536x – 1580.7).
Accuracy studies showed mean recoveries of 100.36% for Lidocaine and 100.29% for Prilocaine, indicating the method’s reliability. Assay results further confirmed satisfactory drug content with mean values of 100.34% and 100.24%, respectively. Robustness testing under varied flow rates (0.8, 1.0, and 1.2 mL/min) produced %RSD values below 0.125% for both analytes, indicating that deliberate changes in chromatographic conditions did not significantly affect performance.
Overall, the developed RP-HPLC method is accurate, sensitive, linear, precise, and robust, making it highly suitable for routine quantitative analysis and quality control of Lidocaine and Prilocaine in pharmaceutical dosage forms.
Cite This Article:
Please cite this article in press Gollu vamsi krishna et al., Method Development And Validation For The Simultaneous Estimation Of Lidocaine And Prilocaine In Bulk And Pharmaceutical Dosage From By RP-HPLC, Indo Am. J. P. Sci, 2025; 12(11).
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