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Sci. Pharm. 2016, 84(2), 279-287; doi:10.3797/scipharm.1506-01

Development and Validation of a Stability- Indicating RP-HPLC Method for the Assay of Pristinamycin in Bulk and Tablet Dosage Form

1
Research & Development, Jawaharlal Nehru Technological University, Kakinada-533003. Andhra Pradesh, India
2
Department of Pharmaceutical Analysis and Quality Assurance, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India
*
Author to whom correspondence should be addressed.
Received: 6 July 2015 / Accepted: 22 July 2015 / Published: 22 July 2015
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Abstract

Pristinamycin is an antibiotic used mainly in the treatment of Staphylococcus infections. The aim of this study was to develop a rapid and simple stability-indicating RP-HPLC method for the determination of pristinamycin in tablet dosage form. Pristinamycin was eluted on the ACE-5, C18-HL, 250 x 4.6 mm, 5 µm analytical column with a mobile phase consisting of 0.2% orthophosphoric acid and acetonitrile 63:37 v/v, pumped at 1.5 ml/min flow rate. The column was maintained at 40°C and 10 μl of the solutions were injected. UV detection was performed at 206 nm. The procedure separated pristinamycin and its potential degradation products in an overall analysis time of less than 10 min with pristinamycin eluting at about 3 min. The method was validated according to the regulatory guidelines with respect to specificity, precision, accuracy, linearity, and robustness. Forced degradation studies were also performed for pristinamycin bulk drug samples to demonstrate the stability-indicating power of the HPLC method. The % RSD of system precision and method precision was found to be 0.64 and 1.49%, respectively. The procedure provided a linear response over the concentration range 25-150 μg/ml (r = 0.9998). Finally, the applicability of the method was evaluated in the tablet dosage form as well as in stability samples.
Keywords: Pristinamycin; Antibiotic; Staphylococcal; HPLC; Stability Pristinamycin; Antibiotic; Staphylococcal; HPLC; Stability
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

MALLIKARJUNA RAO, N.; GOWRISANKAR, D. Development and Validation of a Stability- Indicating RP-HPLC Method for the Assay of Pristinamycin in Bulk and Tablet Dosage Form. Sci. Pharm. 2016, 84, 279-287.

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