A New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Pyridoxine Hydrochloride and Meclizine Hydrochloride in Pharmaceutical Solid Dosage Forms

Abstract

A simple, specific, accurate, precise stability indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of pyridoxine hydrochloride (PYH) and meclizine hydrochloride (MEH). An isocratic separation of PYH and MEH were achieved on C 18, 250 × 4.6 mm ID, 5 m particle size columns at column oven temperature 37 ∘ C with a flow rate of 0.5 mL min −1 and using a diode array detector to monitor the detection at 254 nm. The mobile phase consisted of buffer : acetonitrile : trifluoroacetic acid at a ratio of 30 : 70 : 0.1 (v/v). The retention times of PYH and MEH was found to be 5.25 and 10.14 min, respectively. Suitability, specificity, linearity, accuracy, precision, stability, and sensitivity of this method for the quantitative determination of the drugs were proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) Q2 (R1) guidelines. The proposed method is reliable and robust and can be used as quality control tool for the estimation of these drugs in combined pharmaceutical solid dosage forms.

Simultaneous analysis of two drugs used as supportive treatment for COVID-19: comparative statistical studies and analytical ecological appraisal

“…Both the suggested and reported procedures were analyzed side-by-side to determine whether one was more reliable (Table 8 ). Based on the data, it was determined that the RSM for MZH and Direct determination for PYH had the lowest LOD and lowest LOQ in comparison to the HPLC reported methods [ 17 , 20 ].…”

Impurity‐profiling UPLC methods for quantitative analysis of some antiemetics formulated with pyridoxine

“…To the best of our knowledge, PYR was determined with either MEC or CYC using different analytical methods, such as spectrophotometry (Arayne, Sultana, Siddiqui, Zuberi, & Mirza, 2007; El‐Gindy, 2003; El‐Gindy, Emara, & Mostafa, 2004; Habib, Abdelwhab, Abdelrahman, & Ali, 2016; Sharma, Sharma, Saxena, & Talwar, 1989; Shinde, Sayyed, Chaudhari, Chaware, & Biyani, 2016), HPLC (Al‐Jallad, Al‐Kurdi, Badwan, & Jaber, 1999; Arayne, Sultana, & Siddiqui, 2008; El‐Gindy, Emara, & Mostafa, 2004; Li & Lu, 2005; Mao & Carr, 2001; Nawaz, 2013; Sher et al, 2014), and chemometric/UV methods (El‐Gindy, 2003; El‐Gindy, Emara, & Mostafa, 2004). Moreover, MEC was determined using LC stability‐indicating assay method (LC‐SIAM) in tablets (Peraman, Manikala, Kondreddy, & Yiragamreddy, 2015).…”

Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography Method for Simultaneous Estimation of Methylcobalamin, Alpha-Lipoic Acid, Pyridoxine Hcl, and Folic Acid in Bulk and Combined Dosage Form

“…Folate is used to synthesize, repair, and methylate deoxyribonucleic acid [8]. According to literature review some methods are developed and validated by using different techniques like High performance liquid chromatography [9,10], ultra performance liquid chromatography [11], ultravoiletvisible [12] technique with other combination of drugs. The proposed method aimed to develop and validate a stability-indicating method for the estimation of methylcobalamin, alpha-lipoic acid, pyridoxine hydrochloride, and folic acid in bulk and combined dosage form by reverse-phase high-performance liquid chromatography (Figs.…”