Next Article in Journal
Development of a Stability-Indicating Stereoselective Method for Quantification of the Enantiomer in the Drug Substance and Pharmaceutical Dosage Form of Rosuvastatin Calcium by an Enhanced Approach
Previous Article in Journal
Effect of Nicotinamide on the Photolysis of Riboflavin in Aqueous Solution
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2016, 84(2), 305-320; doi:10.3797/scipharm.1507-09

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

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.
Received: 11 July 2015 / Accepted: 27 August 2015 / Published: 27 August 2015
Download PDF [449 KB, uploaded 7 September 2016]

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
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).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

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.

Show more citation formats Show less citations formats

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Sci. Pharm. EISSN 2218-0532 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top