This paper is published in Volume-4, Issue-4, 2018
Area
Pharmaceutical Analysis
Author
Shweta More
Co-authors
Pratima Tatke
Org/Univ
CU Shah College of Pharmacy, Mumbai, Maharashtra, India
Pub. Date
10 July, 2018
Paper ID
V4I4-1205
Publisher
Keywords
Pregabalin, RP-HPLC, Stability indicating method

Citationsacebook

IEEE
Shweta More, Pratima Tatke. Development and Validation of Stability-indicating method for the determination of Pregabalin by RP-HPLC, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.

APA
Shweta More, Pratima Tatke (2018). Development and Validation of Stability-indicating method for the determination of Pregabalin by RP-HPLC. International Journal of Advance Research, Ideas and Innovations in Technology, 4(4) www.IJARIIT.com.

MLA
Shweta More, Pratima Tatke. "Development and Validation of Stability-indicating method for the determination of Pregabalin by RP-HPLC." International Journal of Advance Research, Ideas and Innovations in Technology 4.4 (2018). www.IJARIIT.com.

Abstract

Pregabalin is an anticonvulsant drug used for neuropathic pain. Pregabalin binds to the alpha-2-delta subunit of the voltage-gated calcium channel in the central nervous system. The aim of the present study was to develop the stability indicating, highly accurate precise and linear method for a related substance of the Pregabalin through the reverse phase HPLC and to validate as per the current ICH guideline. The optimize method uses a reverse phase column, Inertsil ODS 3V (250 mm × 4.6 mm, 5µ), mobile Phase of Di-ammonium hydrogen phosphate buffer (6.5 ± 0.05) and Acetonitrile through gradient flow rate of 0.8 ml/min. Keeping the column at temperature 25°C and using the sample amount 20 µL and detected all the impurities at 210 nm by the UV detector. In the developed method, elution of Pregabalin was at 11.5 min and all the eluted impurities were well separated and met the system suitability criteria. The precision is exemplified by a relative standard deviation of 1.4%. Method percentage mean recoveries of all the impurities are within the range (90.0% to 115.0%) as per the protocol. The method was found to be robust. Linearity coefficient for all Impurities was more than 0.999. The LOD obtained was 0.004% and LOQ is 0.012%. Stability-indicating forced degradation established studies to show results that there was no interference of any degraded products or external environment. A new highly accurate, precise and stability indicating method was developed for a related substance of Pregabalin with all the impurities well separate from the degradation product of Pregabalin.
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