DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR THE ESTIMATION OF DROTAVERINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMAbstract
Drotaverine (DRO) is an anti-spasmodic medication inhibiting phosphodiesterase-4, an enzyme that breaks down cyclic adenosine monophosphate (cAMP). PDE4 inhibition causes an increase in cAMP, which causes smooth muscle relaxation. For DRO, especially the HPTLC technique and stability indicating studies through HPTLC method have not been reported properly in any database. The current research focuses only on a significantly improved HPTLC-based exact, accurate, and specific approach for DRO identification in the presence of degradation constituents employing densitometric detection.DRO was spotted in 6 mm bandwidths with a Camag 100L sample syringe (Hamilton, Switzerland) on a silica gel G60 F254 pre-coated HPTLC aluminium plate with a thickness of 250 µm using a Camag® Linomat-IV applicator. The application rate was 0.4 L/s, with a 6 mm separation between the two bands. Linear ascending development was carried out in a 20 cm × 10 cm twin trough glass chamber, which was then saturated with the mobile phase (Toluene: Methanol; 7:3 v/v).The method was found to be linear over the 200-1200 ng/band range. The stability-indicating method demonstrated desired accuracy, higher precision, better robustness, significantly good LOD and LOQ values, and optimized systems suitability parameters.DRO showed degradation in acidic, alkaline, thermal and oxidative conditions. However, the extent of degradation was different. The method for quantifying DRO has been developed to be quick, precise, accurate, and selective and can be utilized to determine bulk medicines and pharmaceutical dosage forms quickly and easily.
Prashant D. Ghode *, Asawari D. Pachauri, Atul S. Sayare, Ankita Gaware, Rohit Chaudhari, K. R. Khandelwal and Shweta P. Ghode
Department of Pharmaceutical Quality Assurance, JSPM’s Rajarshi Shahu College of Pharmacy and Research, Pune, Maharashtra, India.
20 July 2022
05 April 2023
17 April 2023
01 May 2023