Method Development and Validation for the Simultaneous Estimation of Pregabalin, Methylcobalamin and Nortriptyline in Sustained Release Tablet Dosage Form Using UV-Spectrophotometry
Sonali Sonulkar *
NCRD’s Sterling Institute of Pharmacy, Nerul Navi-Mumbai, 400706, Maharashtra, India.
Khush R. Jain
D. Y. Patil University School of Pharmacy, Nerul, Navi-Mumbai, 400706, Maharashtra, India.
Fariah F. Rizwani
D. Y. Patil University School of Pharmacy, Nerul, Navi-Mumbai, 400706, Maharashtra, India.
Rakesh Somani
D. Y. Patil University School of Pharmacy, Nerul, Navi-Mumbai, 400706, Maharashtra, India.
Rupesh Pingale
NCRD’s Sterling Institute of Pharmacy, Nerul Navi-Mumbai, 400706, Maharashtra, India.
*Author to whom correspondence should be addressed.
Abstract
To method develop and validate simple, linear, rapid, cost effective, precise, accurate and economical for the simultaneous estimation of Pregabalin, Methylcobalamin and Nortriptyline in sustained release tablet dosage form using UV-Spectrophotometry. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV- Spectroscopic method was developed for estimation of Pregabalin, Methylcobalamin and Nortriptyline in sustained release tablet dosage form and also validated as per ICH guidelines. The method is based on measurement of absorbance at three wavelengths 219 nm, 222 nm, and 239 nm in Ethanol and distilled water. Linearity graph of Pregabalin, Methylcobalamin and Nortriptyline were found to be linear in the concentration ranges of 30-150 µg/ml, 0.6-3.0 µg/ml and 2-10 µg/ml. The correlation coefficient (R2) values at three wavelengths 219 nm, 222 nm, and 239 nm for Pregabalin are 0.9996, 0.9929, and 0.9996; for Methylcobalamin (R2) values are 0.9998, 0.9991, and 0.9997; for Nortriptyline (R2) values are 1.0, 0.9992 and 0.9997. The low % RSD values indicate method to be accurate and precise. The % recoveries of Pregabalin, Methylcobalamin and Nortriptyline were in the range of (99.30%-1-1.61%), (98.89%-100.02%) and (99.69%-100.23%) which was within standard acceptance limits. All other validation parameters were performed by following respective ICH guidelines.
Keywords: Pregabalin, Methylcobalamin, Nortriptyline, Simultaneous equation method, UV-Spectrophotometer, ICH guidelines, Validation
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References
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