Development and Validation of a Rapid Chemometrics Assisted RP-HPLC with PDA Detection Method for the Simultaneous Estimation of Pyridoxine HCl and Doxylamine Succinate in Bulk and Pharmaceutical Dosage Form

Table 5

Validation results of developed and optimized reverse phase chromatographic method.

Parameter	PYH (avg. %)	DOX (avg. %)
Specificity	No interference
Accuracy
50%	102.23	100.10
75%	100.60	98.47
100%	98.72	100.61
125%	100.50	99.87
150%	100.61	100.37
Precision—Repeatability
0 hrs	99.26	99.34
8 hrs	99.18	99.34
16 hrs	99.20	99.33
Precision—Intermediate
Day-1	99.29	100.42
Day-2	99.42	99.89
Day-3	98.90	98.37
Instrument-1	99.41	99.34
Instrument-2	101.24	100.25
Analyst-1	100.20	99.35
Analyst-2	100.26	99.34
Lab-1	99.42	99.31
Lab-2	99.96	99.33
Robustness
Flow rate	0.9 mL/min	99.28	99.69
	1.1 mL/min	99.25	100.24
Wavelength	+2 nm	98.20	99.31
	−2 nm	101.68	99.40
Mobile phase	+2%	99.73	100.11
	−2%	100.21	100.26
pH	+0.05	100.23	99.96
	−0.05	99.42	100.28
Assay		100.24	101.39