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Volume 84
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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Article

High-Performance Liquid Chromatographic and High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Dolutegravir Sodium in Bulk Drug and Pharmaceutical Dosage Form

by
Girija B. BHAVAR
1,*,
Sanjay S. PEKAMWAR
2,
Kiran B. AHER
1,
Ravindra S. THORAT
1 and
Sanjay R. CHAUDHARI
1
1
Department of Pharmaceutical Chemistry, Amrutvahini College of Pharmacy, Sangamner – 422608, Maharashtra, India
2
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded – 431606, Maharashtra, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2016, 84(2), 305-320; https://doi.org/10.3797/scipharm.1507-09
Submission received: 11 July 2015 / Accepted: 27 August 2015 / Published: 27 August 2015
Versions Notes

Abstract

Simple, sensitive, precise, and specific high-performance liquid chromategraphic (HPLC) and high-performance thin-layer chromatographic (HPTLC) methods for the determination of dolutegravir sodium in bulk drug and pharmaceutical dosage form were developed and validated. In the HPLC method, analysis of the drug was carried out on the ODS C18 column (150 × 4.6 mm, 5 μm particle size) using a mixture of acetonitrile: water (pH 7.5) in the ratio of 80:20 v/v as the mobile phase at the flow rate 1 mL/min at 260 nm. This method was found to be linear in the concentration range of 5-35 μg/mL. The peak for dolutegravir sodium was observed at 3.0 ± 0.1 minutes. In the HPTLC method, analysis was performed on aluminum-backed plates pre-coated with silica gel G60 F254 using methanol: chloroform: formic acid in the proportion of 8:2:0.5 v/v/v as the mobile phase. This solvent system was found to give compact spots for dolutegravir sodium with the Rf value 0.77 ± 0.01. Densitometric analysis of dolutegravir sodium was carried out in the absorbance mode at 265 nm. Linear regression analysis showed good linearity with respect to peak area in the concentration range of 200-900 ng/spot. The methods were validated for precision, limit of detection (LOD), limit of quantitation (LOQ), accuracy, and specificity. Statistical analysis showed that both of the methods are repeatable and specific for the estimation of the said drug. The methods can be used for routine quality control analysis of dolutegravir sodium.
Keywords: Dolutegravir sodium; HPLC; Forced Degradation; HPTLC; Validation Dolutegravir sodium; HPLC; Forced Degradation; HPTLC; Validation

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MDPI and ACS Style

BHAVAR, G.B.; PEKAMWAR, S.S.; AHER, K.B.; THORAT, R.S.; CHAUDHARI, S.R. High-Performance Liquid Chromatographic and High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Dolutegravir Sodium in Bulk Drug and Pharmaceutical Dosage Form. Sci. Pharm. 2016, 84, 305-320. https://doi.org/10.3797/scipharm.1507-09

AMA Style

BHAVAR GB, PEKAMWAR SS, AHER KB, THORAT RS, CHAUDHARI SR. High-Performance Liquid Chromatographic and High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Dolutegravir Sodium in Bulk Drug and Pharmaceutical Dosage Form. Scientia Pharmaceutica. 2016; 84(2):305-320. https://doi.org/10.3797/scipharm.1507-09

Chicago/Turabian Style

BHAVAR, Girija B., Sanjay S. PEKAMWAR, Kiran B. AHER, Ravindra S. THORAT, and Sanjay R. CHAUDHARI. 2016. "High-Performance Liquid Chromatographic and High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Dolutegravir Sodium in Bulk Drug and Pharmaceutical Dosage Form" Scientia Pharmaceutica 84, no. 2: 305-320. https://doi.org/10.3797/scipharm.1507-09

APA Style

BHAVAR, G. B., PEKAMWAR, S. S., AHER, K. B., THORAT, R. S., & CHAUDHARI, S. R. (2016). High-Performance Liquid Chromatographic and High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Dolutegravir Sodium in Bulk Drug and Pharmaceutical Dosage Form. Scientia Pharmaceutica, 84(2), 305-320. https://doi.org/10.3797/scipharm.1507-09

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