Quantitative Reverse-phase High-performance Liquid Chromatographic Method for the Quantification of Raltegravir Potassium in Bulk and Dosage Forms

Abstract

Objectives: The aim of this present study is to develop an accurate, precise and linear Reverse-phase High-performance Liquid Chromatographic (RP-HPLC) method for the estimation of raltegravir potassium in the bulk and pharmaceutical dosage form. Methods: The chromatographic system employs a reverse phase shim-pack C 18 column, (150 x 4.6 mm; 5 μ) using the mobile phase acetonitrile: (0.05 M) ammonium acetate buffer, (pH-4 adjusted with glacial acetic acid) in the proportion of 50:50 v/v, delivered at a flow rate of 0.8 ml/min with the detection wavelength of 271 nm. Results: The developed method resulted in the retention of raltegravir at 4.31 min. Raltegravir potassium exhibited linear relationship (r 2 > 0.9999) over the analytical range 10-50 μg/ml. The precision was exemplified by a relative standard deviation of 1.60 %. The percentage recovery was found to be in the range of 100-102 %, during accuracy studies. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) was found to be 0.104 µg/ml and 0.315 µg/ml, respectively. Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of raltegravir potassium in (20 mg, 50 mg) tablet as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.

Simultaneous quantification of (E) and (Z) isomers of rilpivirine and four degradation products in bulk and tablets by reversed‐phase ultra‐high‐performance liquid chromatography and confirmation of all by molecular weight

“…(9) Comprehensive data generated with a PDA detector and an MS detector is useful for the correct identification and confirmation of peaks based on spectra and molecular weight. (10) The molecular weight of an unspecified degradation product or peak will be helpful to identify or predict the root cause or source of contamination in the analysis.…”

“…Several different techniques have been described in the literature for the estimation of rilpivirine in pharmaceutical and biological samples. A thorough literature review study demonstrated that different analytical techniques were used for the estimation of rilpivirine as a single content using spectrophotometric [4,5], HPTLC [6], HPLC [7][8][9][10], UPLC [11], LC-MS [12], and LC-MS/MS [13][14][15] in different matrixes (bulk, tablets, nanoparticles, saliva, serum, and human plasma). The literature also revealed the number of methods including RP-HPLC [16][17][18][19][20][21][22][23][24][25][26], HPLC-MS/MS [27][28][29][30][31], RP-UPLC [32][33], and UPLC-MS/MS [34][35][36] for the determination of rilpivirine in the presence of other antiretroviral drug molecules.…”