Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms

Abstract

Ombitasvir, ritonavir and paritaprevir are three recently discovered directly acting antiviral drugs (DAADs) used in combined single dose tablet dosage form for treatment of hepatitis-C viral infections (HCV). The methods of analysis followed by quality control and research laboratories are required to be economic and fast; however, these methods can also produce huge amounts of chemical waste. In this study two fast, economic and green HPLC and HPTLC methods were validated for the simultaneous determination of the three drugs. For HPLC, isocratic elution used a mixture of micellar aqueous mobile phase consisting of (0.15 M sodium lauryl sulfate and 0.01 M sodium dihydrogen phosphate, pH 6.2) and ethanol (56:44). Elution was done on RP-C18 Kinetix® column (5 μm, 150 mm × 4.6 mm ID) at flow 1 mL min -1 and 254 nm UV-detector. HPTLC separations were performed on Merck® (20 cm × 10 cm) aluminum HPTLC plates coated with silica gel 60F254 using a mobile phase, Methylene chloride: methanol: ethyl acetate: ammonia (25%), (5:1:3:1, v/v/v/v) respectively. The calibration curves were linear across ranges of 3–100 μg mL -1 and 0.1–2 μg/spot for both HPLC and HPTLC methods, respectively. The two methods were applied successfully for the determination of the three drugs under study in their combined tablets dosage forms.

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

“…The proposed method was compared to reported HPLC method 12 and UHPLC method 14 using GAPI. Figure 5 shows the GAPI pictograms for the three methods.…”

“…Literature review revealed that few methods were reported for the simultaneous determination of OMB, PAR, and RIT, all based on chromatographic analysis techniques. Eight papers described High Performance Liquid Chromatography (HPLC) methods using isocratic mobile phase 6–13 and two Ultra‐High Performance Liquid Chromatography (UHPLC) methodologies were reported utilizing MS/MS detection 14,15 . No UV spectroscopic methods were reported for the simultaneous determination of the three antiviral drugs under study.…”

An eco-friendly micellar HPLC method for the simultaneous determination of triamterene and xipamide in active pharmaceutical ingredients and marketed tablet dosage form

“…Several metrics are being used for evaluation of analytical procedures. The first introduced metric was the National Environmental Methods Index (NEMI) [14]. The analytical eco-scale reported in 2012 [23] calculates penalty points for any step in the analytical procedure that doesn't match green chemistry ideas.…”

“…Most of these are chromatographic methods focusing on identification of the drugs under study together with other diuretics and CNS stimulants in urine for purpose of doping control using ultra-high performance liquid chromatography (UHPLC) with MS/MS detection [6][7][8] or high performance liquid chromatography (HPLC) coupled with MS/MS detector [9][10][11][12][13]. Such reported methods are expensive due to the high cost of mass detectors especially when coupled with UHPLC due to the added working and maintenance cost and hence not favored by users in pharmaceutical economic facilities who require more simple and cheap methodologies for the analysis purposes [14]. Other methods were reported using HPLC with UV/VIS detection [15,16].…”

Formulation and Evaluation of Cefixime Nanosuspension for the Enhancement of Oral Bioavailability by Solvent-Antisolvent Method and its Suitable Method Development

“…Each sample was filtered and the amount of cefixime dissolved was determined using a UV Spectrophotometer at a wavelength of 287nm. [14][15][16] Antimicrobial studies…”