Validated stability-indicating RP-HPLC technique for concurrent measurement of Doxylamine succinate and Pyridoxine hydrochloride related component in combination dosage form

Abstract

Pyridoxine hydrochloride is a vital water-soluble vitamin that serves an essential function in the synthesis of hemoglobin. Doxylamine succinate is an antihistaminic with antimuscarinic and stated sedative. It is commercially available as coated tablets at the dosage of 10/10 mg. There is no official monograph of this formulation in the current international pharmacopoeias. This article presents a simple, specific, accurate and stability indicating high-performance liquid chromatographic method for instantaneous determination of Doxylamine succinate and Pyridoxine hydrochloride related substances in combined dosage formula. The mobile phase consists of Mobile phase A (Buffer) and mobile phase B (Methanol) in gradient program for good separation of Doxylamine succinate and Pyridoxine hydrochloride and their related substances. A column holding octyl silane (C8) chemically bonded to porous silica particles (Chromosil®, C8, 250 x 4.6 mm, 5 µm) was used as stationary phase. Detection was performed using a variable wavelength ultraviolet-visible detector adjusted to 262 nm for Doxylamine succinate known impurities and 292 nm for Pyridoxine hydrochloride known impurities. Solutions were introduced into the HPLC system using gradient program at a constant flow rate of 1.0 mL/min under controlled column and sampler temperature. The HPLC method was found to be stability indicating and separate all peaks of interest by gradient elusion within 30 minutes. The method was validated in accordance with the standards outlined in the International Conference on Harmonization guidelines Q2(R1) and values of all the parameters found within acceptable limits. The simultaneous estimation HPLC method for Doxylamine succinate and Pyridoxine hydrochloride related substances was successfully developed and validated as mentioned in guidelines and it is found to be precise, specific, accurate and stability indicating. The linearity of known impurities found >0.99 in the range 10% to 150% of the target concentration. Recovery of the known impurities found within satisfactory range Likewise, the accuracy at the limit of quantification level yields satisfactory outcomes. The data consistently demonstrates the effectiveness of these methods, which can be employed for regular commercial release and stability assessments of pharmaceutical dosage forms.