Method development and Validation of an RP-HPLC Method for Simultaneous Determination of Pregabalin and Nortriptyline hydrochloride in Pharmaceutical Dosage Form.

Author(s)	Prof. Dr. A. M. Tamboli, Mr. Vinay Shivaji Kamble, Mr. Sourabh Rajendra Bhosale, Mr. Swapnil Bajirao Hole
Country	India
Abstract	The assay of Pregabalin and Nortriptyline hydrochloride was performed with tablets and the % assay was found to be 99.46 & 99.50% which shows that the method is useful for routine analysis. The linearity of Pregabalin and Nortriptyline hydrochloride was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.37 and 0.18 for Pregabalin and Nortriptyline hydrochloride which shows that the method is precise. Which shows that the method is repeatable when performed in different days also. The total recovery was found to be 99.39-100.45 % and 99.32-99.37%, for Pregabalin and Nortriptyline hydrochloride. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility.
Keywords	Pregabalin, Nortriptyline, RSD, accuracy
Field	Medical / Pharmacy
Published In	Volume 7, Issue 3, May-June 2025
Published On	2025-06-22

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