International Journal Of Drug Delivery Technology
Volume 16, Issue 4, 2026

Simultaneous Estimation Of N-Acetyl Cysteine And Pyridoxamine Dihydrochloride In It'S Bulk Drug And Pharmaceutical Dosage Form By Hptlc Method

Girishankar H. Bhavale1, Dr. Madhuri U. Shelar1*, Dr. Jyoti N. Kadam2, Dr. Ganesh S. Andhale3, Dr. Priyanka Gondhale-Karpe4, Dr. Nilesh Y. Jadhav2, Dr. Jeevan S. Dhumal5, Dr. Rajendra D. Dighe6

1 Department Of Pharmaceutical Quality Assurance, Alard University School Of Pharmacy, Marunji, Tal. Mulshi, Pune (411057), Maharashtra, India.

2 Department Of Pharmaceutical Chemistry, Rjspm'S College Of Pharmacy, Dudulgaon, Pune (412105), Maharashtra, India.

3 Department Of Pharmaceutical Chemistry, Alard University School Of Pharmacy, Marunji, Tal. Mulshi, Pune (411057), Maharashtra, India.

4 Department Of Pharmaceutical Chemistry, School Of Pharmacy, Vishwakarma University Vu Pune (411048), Maharashtra, India.

5 Department Of Pharmacognosy, Rjspm'S College Of Pharmacy, Dudulgaon, Pune (412105), Maharashtra, India.

6 Sandip Foundation'S Sandip Institute Of Pharmaceutical Sciences, Mahirawani, Trimbak Road, Nashik (422213), Maharashtra, India.

Corresponding Author: Dr. Madhuri U. Shelar, Department Of Pharmaceutical Quality Assurance, Alard University School Of Pharmacy, Marunji, Tal. Mulshi, Pune (411057), Maharashtra, India. Email: madhurishelar70@yahoo.com

Received: 20th Feb, 2026; Revised: 4th Mar, 2026; Accepted: 25th Mar, 2026; Available Online: 10th Apr, 2026

Abstract

A simple, precise, and cost-effective high-performance thin-layer chromatographic (hptlc) method was developed and validated for the simultaneous estimation of n-acetyl cysteine (nac) and pyridoxamine dihydrochloride (pyri 2hcl) in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using silica gel 60f254 plates with a mobile phase consisting of methanol:toluene:formic acid (3:7:0.1 v/v/v). Densitometric analysis was performed at 212 nm. The rf values for nac and pyri 2hcl were found to be 0.42 and 0.13, respectively. The method showed good linearity in the range of 30–180 ng/band for nac and 5–30 ng/band for pyri 2hcl with correlation coefficients of 0.997 and 0.994. The method was validated as per ich guidelines and demonstrated acceptable accuracy, precision, sensitivity, robustness, and specificity. The developed method was successfully applied for the analysis of marketed formulations. Hence, the method can be used for routine quality control analysis.

Keywords: N-Acetyl Cysteine, Pyridoxamine Dihydrochloride, High Performance Thin Layer Chromatography, Validation.

How To Cite This Article: Bhavale Gh, Shelar Mu, Kadam Jn, Andhale Gs, Gondhale-Karpe P, Jadhav Ny, Dhumal Js, Dighe Rd. Simultaneous Estimation Of N-Acetyl Cysteine And Pyridoxamine Dihydrochloride In It'S Bulk Drug And Pharmaceutical Dosage Form By Hptlc Method. Int J Drug Deliv Technol. 2026;16(4):425. Doi: 10.25258/ijddt.16.4.41