Quality by design optimization and validation of a HPTLC-MS method for simultaneous estimation of paracetamol and prochlorperazine from bulk and formulation

Study reports that the, stability indicating high-performance thin layer chromatographic technique (HPTLC) was developed as well as validated for estimating Paracetamol and Prochlorperazine in bulk and dosage form. These drugs are largely used in migraine and first line treatment of schizophrenia. Selected drug combination employed for Quality by design based Box Behnken design by high performance thin layer chromatography method uti-lizing aluminium plates; pre-coated using silica gel 60F254 as stationary phase by using acetone: toluene: methanol (4:4:2 v/v/v) as a mobile phase. Densitogram shows Rf values for Paracetamol at 0.74 and for Pro-chlorperazine at 0.32 evaluated by densitometry measurement bands at 248 nm. Paracetamol and Pro-chlorperazine marketed formulation of 700 mg by using various excipients prepared at lab scale and it was evaluated for various types of tablet tests, and it showed the accurate result with respect to standard guidelines. The approach has been validated in accordance with International Conference on Harmonization (ICH) re-quirements. The correlation coefficient was found to be 0.992 and 0.998 at a concentration range of 100-300 mu g/ band and 1000-3000 ng/band for Paracetamol and Prochlorperazine, respectively. The method had an accuracy of 100.51 % and 100.53 % for Paracetamol and Prochlorperazine, respectively. The degradation of Paracetamol and Prochlorperazine was carried out in an acid, alkaline, oxidative, thermal and photolytic environment. The stress degraded product was successfully separated using the HPTLC and using high resonance mass spectroscopy technique (HRMS-MS), the degradation product was discovered.