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Volume 81
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Article

Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms

by
Thummala Veera Raghava RAJU
1,*,
Raja Kumar SESHADRI
1,
Srinivas ARUTLA
1,
Tharlapu Satya Sankarsana Jagan MOHAN
1,
Ivaturi Mrutyunjaya RAO
2 and
Someswara Rao NITTALA
2
1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500072, India
2
School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2013, 81(1), 123-138; https://doi.org/10.3797/scipharm.1209-17
Submission received: 27 September 2012 / Accepted: 5 November 2012 / Published: 5 November 2012
Versions Notes

Abstract

A novel, sensitive, stability-indicating HPLC method has been developed for the quantitative estimation of Tolperisone-related impurities in both bulk drugs and pharmaceutical dosage forms. Effective chromatographic separation was achieved on a C18 stationary phase with a simple mobile phase combination delivered in a simple gradient programme, and quantitation was by ultraviolet detection at 254 nm. The mobile phase consisted of a buffer and acetonitrile delivered at a flow rate 1.0 ml/min. The buffer consisted of 0.01 M potassium dihydrogen phosphate with the pH adjusted to 8.0 by using diethylamine. In the developed HPLC method, the resolution between Tolperisone and its four potential impurities was found to be greater than 2.0. Regression analysis showed an R value (correlation coefficient) of greater than 0.999 for the Tolperisone impurities. This method was capable of detecting all four impurities of Tolperisone at a level of 0.19 μg/mL with respect to the test concentration of 1000 μg/mL for a 10 μl injection volume. The tablets were subjected to the stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation. Considerable degradation was found to occur in base hydrolysis, water hydrolysis, and oxidation. The stress samples were assayed against a qualified reference standard and the mass balance was found to be close to 100%. The established method was validated and found to be linear, accurate, precise, specific, robust, and rugged.
Keywords: Tolperisone; Validation; Impurities; Degradation; HPLC Tolperisone; Validation; Impurities; Degradation; HPLC

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MDPI and ACS Style

RAJU, T.V.R.; SESHADRI, R.K.; ARUTLA, S.; MOHAN, T.S.S.J.; RAO, I.M.; NITTALA, S.R. Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms. Sci. Pharm. 2013, 81, 123-138. https://doi.org/10.3797/scipharm.1209-17

AMA Style

RAJU TVR, SESHADRI RK, ARUTLA S, MOHAN TSSJ, RAO IM, NITTALA SR. Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms. Scientia Pharmaceutica. 2013; 81(1):123-138. https://doi.org/10.3797/scipharm.1209-17

Chicago/Turabian Style

RAJU, Thummala Veera Raghava, Raja Kumar SESHADRI, Srinivas ARUTLA, Tharlapu Satya Sankarsana Jagan MOHAN, Ivaturi Mrutyunjaya RAO, and Someswara Rao NITTALA. 2013. "Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms" Scientia Pharmaceutica 81, no. 1: 123-138. https://doi.org/10.3797/scipharm.1209-17

APA Style

RAJU, T. V. R., SESHADRI, R. K., ARUTLA, S., MOHAN, T. S. S. J., RAO, I. M., & NITTALA, S. R. (2013). Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms. Scientia Pharmaceutica, 81(1), 123-138. https://doi.org/10.3797/scipharm.1209-17

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